- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05191277
Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation (PHEA)
Disentangling Pharmacological and Expectation Effects in Antidepressant Discontinuation - a Randomized, Balanced Open-hidden Trial
Antidepressant medication is established as an evidence-based, guideline-recommended treatment for Major Depressive Disorders. In the past decades, prescriptions of antidepressant medication have markedly increased, with a specific surge in maintenance prescriptions and therefore, long-term intake, despite guideline recommendations to discontinue antidepressant medication after maintenance therapy has been completed.
Over half of fully remitted patients who attempt to discontinue their antidepressant medication report adverse discontinuation symptoms. For many patients, discontinuation symptoms are so severe, that they do not manage to complete their discontinuation attempt. While discontinuation symptoms, deterioration of depressive symptoms, and recurrence can result from pharmacological effects of antidepressant discontinuation, patients' expectations towards discontinuation are likely to play an essential role in occurrence, too.
The aim of the present study is to explore the interplay of expectations and pharmacological effects in antidepressant discontinuation. Participants who fulfill German national S3 guideline recommendations will receive a 1:1 chance to either discontinue their antidepressant medication or remain on their antidepressant medication. In addition, participants' expectations are intended to be manipulated by varying verbal instructions using the open-hidden paradigm. Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation). Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation). Participants will have a 1:1:1:1 chance of being allocated to 1 of the 4 experimental groups: open discontinuation (OD), hidden discontinuation (HD), open continuation (OC), or hidden continuation (HC) of their antidepressant medication.
This preregistration is part of the collaborative research center (CRC) SFB/TRR289 which aims to characterize the psychological and neurobiological effects of treatment expectations on health outcome (https://treatment-expectation.de) and is funded by the Deutsche Forschungsgemeinschaft (DFG).
Study Overview
Status
Conditions
Detailed Description
Antidepressant medication is established as an evidence-based, guideline-recommended treatment for Major Depressive Disorders. Following initial response to antidepressant medication and full remission of depressive symptoms, treatment guidelines generally recommend maintenance therapy for several months in order to prevent relapse and subsequent discontinuation of antidepressant medication. German national S3 guidelines for treating Major Depressive Disorders recommend that patients with a single episode remain on maintenance therapy for at least 4 months, while those with recurring episodes and significant functional impairment persist for at least 24 months. In the past decades, prescriptions of antidepressant medication have markedly increased, with a specific upsurge in maintenance prescriptions and consequential long-term intake, despite guideline recommendations to discontinue antidepressant medication.
Over half of fully remitted patients who attempt to discontinue their antidepressant medication report adverse discontinuation symptoms. For many patients, discontinuation symptoms are so severe, that they do not manage to complete their discontinuation attempt. Additionally, discontinuation of antidepressant medication is associated with elevated risks of deterioration of depressive symptoms and recurrence. While S3 guidelines recommend dose-tapering over at least four weeks when stopping antidepressant medication, precise recommendations on how to minimize the risk of recurrence and the potential burden associated with depressive and discontinuation symptoms are lacking. Discontinuation symptoms, deterioration of depressive symptoms, and recurrence can result from pharmacological effects of antidepressant discontinuation and patients' expectations towards discontinuation are likely to play an essential role in occurrence, too.
The present study aims to explore the interplay of expectations and pharmacological effects in antidepressant discontinuation. Participants who fulfill German national S3 guideline recommendations will receive a 1:1 chance to either discontinue their antidepressant medication or remain on their antidepressant medication. In addition, participants' expectations are intended to be manipulated by varying verbal instructions using the open-hidden paradigm. Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation). Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation). Participants will have a 1:1:1:1 chance of being allocated to 1 of the 4 experimental groups: open discontinuation (OD), hidden discontinuation (HD), open continuation (OC), or hidden continuation (HC) of their antidepressant medication.
The trial will consist of a 13-week experimental phase (1 week run-in, 4 weeks of either discontinuation following a pre-specified tapered dose-reduction scheme or continuation of initially prescribed antidepressant medication, 8 weeks monitoring either off antidepressant medication or on initially prescribed antidepressant medication) and a 39-week clinical observation phase. During run-in, all participants will remain on their prescribed antidepressant medication and initial dose, though newly encapsulated to control for tablet appearance effects. All pills for all participants will look identical throughout the whole trial.
During the subsequent 4 weeks, participants within the hidden arms (HD and HC) will be blinded as to whether they are receiving tapered dose-reduction or their initial antidepressant medication. During the following 8-week monitoring phase, participants within the hidden arms will receive double-blind placebo pills (HD) or double-blind antidepressant medication (HC).
Participants within the open trial arms will either be aware of discontinuing their antidepressant medication during the first 4 weeks following run-in, followed by 8 weeks of receiving open-label placebo pills (OD), or will be aware of remaining on their antidepressant medication (OC) during the entire experimental phase, respectively. At 13-weeks post-baseline, the experimental phase will conclude with the primary outcome measure and patients will be debriefed.
Detailed hypotheses are:
Interaction effect of treatment and treatment expectation: Treatment (continuation vs. discontinuation of antidepressant medication) and treatment expectation (high vs. moderate) interact in modulating discontinuation symptom load among remitted MDD patients over the course of the experimental phase.
Post-hoc comparison on the nocebo-determined effect of expectation: Remitted MDD patients who remain on their antidepressant medication will show a higher discontinuation symptom load with moderate than with high expectation.
Post-hoc comparison on the pharmacological effect of treatment: Remitted MDD patients with moderate treatment expectation will show a higher discontinuation symptom load if antidepressant medication is discontinued versus if antidepressant medication is continued.
Post-hoc comparison on the effect of treatment expectation: Remitted MDD patients who discontinue their antidepressant medication will show a higher discontinuation symptom load with high than with moderate treatment expectation.
Modulating effects of further psychological, physiological, and medical factors on the relationship between treatment expectation and discontinuation symptom load: The relationship between treatment expectation and discontinuation symptom load will vary according to stress ratings, prior side effects of antidepressant medication, prior discontinuation experience, personality traits, sensory amplification and illness framwork.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire Warren, PhD
- Phone Number: +49(0) 40 741059901
- Email: warrenc@hsu-hh.de
Study Contact Backup
- Name: Henning Romberg, MSc
- Email: rombergh@hsu-hh.de
Study Locations
-
-
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Hamburg, Germany, 20251
- Recruiting
- University Medical Center Hamburg-Eppendorf
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Sub-Investigator:
- Tahmine Fadai, MD
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Principal Investigator:
- Yvonne Nestoriuc, Prof. Dr.
-
Contact:
- Claire Warren, PhD
- Phone Number: +49(0) 40 741059901
- Email: warrenc@hsu-hh.de
-
Contact:
- Markus Wim Stratmann, M.Sc.
- Email: m.stratmann@uke.de
-
-
Hessen
-
Marburg, Hessen, Germany, 35037
- Withdrawn
- University of Marburg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients (18 to 75 years) with fully remitted Major Depressive Disorder, single or recurrent, as main diagnosis confirmed by prescribing physician and SCID-5 (American Psychiatric Association, 2013)
- Intake of SSRI/SNRI (citalopram: 20-40mg, escitalopram: 10-20mg, sertraline: 50-150mg, venlafaxine: 75-150mg, duloxetine: 60-100mg, paroxetine: 20-40mg) or NaSSA (mirtazapine: 30-45mg)
- Discontinuation wish by patient supported by prescribing physician
- Fulfils criteria of the German S3 national guideline recommendations for treatment of Major Depressive Disorders to discontinue antidepressant medication: a) response to antidepressant medication, b) symptom remission for at least four months (for a single episode) or two years (for two or more episodes with significant functional impairment) and c) concurrent intake of antidepressant medication (at least 4 weeks on a steady dose)
Exclusion Criteria:
- Acute or chronic somatic illness and/or intake of medication which might interfere with depressive disorder, antidepressant medication or proposed study
- Acute suicidality, psychotic symptoms, substance abuse or addiction, current mania, or hypomania confirmed by SCID-5 (American Psychiatric Association, 2013) or other psychopathology which might interfere with depressive disorder, antidepressant medication or proposed study
- Any history of bipolar disorder or psychosis confirmed by SCID-5 (American Psychiatric Association, 2013)
- Severe stressful life events (e.g., death of a family member) within six months prior to study participation
- Insufficient German language proficiency
- No informed consent
- Upon optional participation: MRI-specific exclusion criteria (phobic anxiety, claustrophobia, ferromagnetic implants, etc.)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open discontinuation (OD)
Participants will discontinue their antidepressant medication and will be fully informed about treatment (i.e., high expectation).
|
Pharmacological intervention: Participants will discontinue their antidepressant medication.
Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm.
Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation).
expectation).
|
Experimental: Hidden discontinuation (HD)
Participants will discontinue their antidepressant medication, but will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).
|
Pharmacological intervention: Participants will discontinue their antidepressant medication.
Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm.
Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).
|
Experimental: Open continuation (OC)
Participants will remain on their initial antidepressant medication and will be fully informed about treatment (i.e., high expectation).
|
Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm.
Within the open trial arms, participants will receive full information about their treatment (i.e., high expectation).
expectation).
Pharmacological intervention: Participants will remain on their antidepressant medication.
|
Experimental: Hidden continuation (HC)
Participants will remain on their initial antidepressant medication, but will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).
|
Psychological intervention: Participants' expectations will be manipulated by varying verbal instructions using the open-hidden paradigm.
Within the hidden trial arms, participants will be informed about a 50% chance of discontinuing versus remaining on their antidepressant medication (i.e., moderate expectation).
Pharmacological intervention: Participants will remain on their antidepressant medication.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discontinuation symptom load over the course of the experimental phase from baseline T0 to primary endpoint T9 - 'Discontinuation Related Signs and Symptoms Scale' (DESS)
Time Frame: Measured as area under the curve (AUC) over the following time points: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]
|
The Discontinuation Related Signs and Symptoms Scale is a self-report questionnaire to assess discontinuation symptoms, incorporating 43 discontinuation symptoms of antidepressants with intensity ratings ranging from 0 (not present) - 3 (severe) each.
Total sum score ranges from 0-129 with higher scores indicating more pronounced discontinuation symptoms.
|
Measured as area under the curve (AUC) over the following time points: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Discontinuation symptom load over the course of the trial from baseline T0 to study completion FU3 - 'Discontinuation Related Signs and Symptoms Scale' (DESS)
Time Frame: Measured as area under the curve (AUC) over the following time points: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
The Discontinuation Related Signs and Symptoms Scale is a self-report questionnaire to assess discontinuation symptoms, incorporating 43 discontinuation symptoms of antidepressants with intensity ratings ranging from 0 (not present) - 3 (severe) each.
Total sum score ranges from 0-129 with higher scores indicating more pronounced discontinuation symptoms.
|
Measured as area under the curve (AUC) over the following time points: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Recurrence
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Appearance of a new, depressive episode after full remission of depressive symptoms and a period of recovery.
Potential recurrence will be monitored weekly during run-in and (dis-) continuation phase, biweekly during monitoring phase, and 6, 9 and 12 months post-baseline based on BDI-II and MADRS scores.
If recurrence is suspected (as indicated by BDI-II scores >19 OR MADRS scores >21 over two weeks/study visits), corresponding SCID-5-CV sections will be conducted to (dis-)confirm recurrence.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Psychophysiological Stress - 'Perceived Stress Scale' (PSS-10)
Time Frame: At baseline (T0) and 13 weeks post baseline at primary endpoint (T9)
|
Self-reported measure of subjective stress, including 10 items with 5 rating categories (0-4), total scores range between 0-40 with higher scores indicating more pronounced stress.
|
At baseline (T0) and 13 weeks post baseline at primary endpoint (T9)
|
Anxiety vs. depression - 'State-Trait-Anxiety-Depression-Inventory' (STADI)
Time Frame: At baseline (T0) and 13 weeks post baseline at primary endpoint (T9); Trait scale measured at baseline only
|
Self-report questionnaire as indicator of state and trait anxiety and depression, divided in 2 sections (state vs. trait) consisting of 20 statements with 4 response options (1-4), respectively.
Total scores per scale range between 20 and 80 with higher sum scores indicating higher state/trait anxiety or depression.
|
At baseline (T0) and 13 weeks post baseline at primary endpoint (T9); Trait scale measured at baseline only
|
Attentional and emotional processing - 'Posner task'
Time Frame: 13 weeks post baseline at primary endpoint (T9)
|
The Posner Task manipulates attentional resources, provokes emotional responses and robustly activates limbic, prefrontal, and visuo-spatial brain circuits.
In short, participants respond as fast as possible to a dot target by button pressing while neutral, happy, sad or fearful face distractors are presented.
Targets are preceded by either spatially-directing cues leading to covert shifts in the attentional focus (i.e., low attentional resources to process distractors) or non-spatial cues leaving the attentional focus on the distractors.
Reaction times will be measured in milliseconds (ms) for each condition, difference scores will be calculated under high attention to faces for happy and neutral faces, sad and neutral faces, as well as fearful and neutral faces.
|
13 weeks post baseline at primary endpoint (T9)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported depressive symptoms - 'Beck Depression Inventory II' (BDI-II)
Time Frame: Screening; weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Self-report measure to assess depressive symptoms, including 21 items with 4 response options (0-3), total scores range from 0-63 with higher scores indicating more pronounced depressive symptoms).
|
Screening; weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Expert-rated depression severity scores - 'Montgomery-Åsberg Depression Rating Scale' (MADRS)
Time Frame: Screening; weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Expert-rated interview to assess the severity of depression by 10 items with up to 7 rating categories (0-6) for each item, total scores range between 0-60 with higher scores indicating more pronounced depressive symptoms.
|
Screening; weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Adherence
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Treatment adherence assessed by a single item in the clinical interview about adherence to intake of study medication during the experimental phase and remaining on or off antidepressant medication during the clinical observation phase, respectively.
Further details will be published elsewhere, a link to the registration of the overarching project Z03 will be added as soon as available.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Magnetic resonance imaging data
Time Frame: Between screening and 1 week post baseline (T1), for OC group up to 4 weeks post baseline (T4).
|
Functional and structural imaging data will be acquired using a 3T MR system (Trio, Siemens Healthcare, Erlangen, Germany at the Institute of Systems Neuroscience, director C. Büchel) with a 64-channel head/neck coil.
All structural and functional images will be acquired using standardized MR protocols as described in, provided by and analyzed in the CRC-overarching central project Z03 to later allow for pooled analysis of harmonized multi-center data ('Mega-analysis').
These include (i) resting state functional MRI (rsfMRI), (ii) 3D-MPRage T1-weighted sequence, and (iii) Diffusion Tensor Imaging (DTI).
Further details will be published in the registration of the CRC-overarching central project Z03, a link will be added as soon as available.
|
Between screening and 1 week post baseline (T1), for OC group up to 4 weeks post baseline (T4).
|
Treatment expectations - 'Treatment Expectation Questionnaire' (TEX-Q)
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]
|
Self-reported measure to assess patients' treatment expectations, consisting of 15 items with 11 response options (0-10), total scores range from 0-150 with higher scores indicating more positive treatment expectations.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]
|
Treatment expectations - 'Generic rating scale for treatment expectations' (GEEEexp)
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
The Generic rating scale for treatment expectations is one of three subscales of the 'Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects' (GEEE).
The subscale Generic rating scale for treatment expectations consists of three items that assess expectations towards treatment on a numeric rating scale with eleven response options (0-10); total scores of all three subscales combined range from 0-30 with higher scores indicating higher treatment expectations.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Side effects of antidepressant medication - 'Generic Assessment of Side Effects' (GASE)
Time Frame: At baseline (T0) and 13 weeks post baseline at primary endpoint (T9)
|
Self-report measure to assess side effects of antidepressant medication, including 36 items (symptom descriptions) with 4 response options (0-3).
Items are additionally evaluated on their relation to antidepressant medication (Yes/ No questions).
Total scores range from 0-108 with higher scores indicating stronger experiences of side effects.
|
At baseline (T0) and 13 weeks post baseline at primary endpoint (T9)
|
Pre-experiences with antidepressant discontinuation - 'Generic rating scale for previous treatment experiences' (GEEEpre)
Time Frame: At baseline (T0)
|
The Generic rating scale for previous treatment experiences is one of three subscales of the 'Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects' (GEEE).
It is a self-reported assessment of previous experiences with treatment, i.e., antidepressant discontinuation.
If experience with antidepressant discontinuation is indicated, the subsequent 3 items rate the experiences on a numeric analogue scale each (ranging from 0-10), total score range from 0-30; higher scores indicate more pre-experiences with antidepressant discontinuation.
|
At baseline (T0)
|
Common biological stress markers
Time Frame: 1 week between screening and baseline
|
Salivary Alpha-Amylase and cortisol levels assessed via saliva sampling.
|
1 week between screening and baseline
|
Personality traits - 'Brief Big Five Inventory' (BFI 10)
Time Frame: At baseline (T0)
|
10-item scale measuring the personality traits Extraversion, Agreeableness, Conscientiousness, Emotional Stability, and Openness to assess the influence of personality traits on treatment outcome at baseline.
The items are rated on a five-step scale from 1 "disagree strongly" to 5 "agree strongly".
The scale consists of 2 BFI items for each Big Five Dimension.
|
At baseline (T0)
|
Behavioral Inhibition/Behavioral Approach (motivational systems) - 'Behavioral Inhibition/Behavioral Approach System' Scale (BIS/BAS)
Time Frame: At baseline (T0)
|
Self-report questionnaire to assess sensitivity to approach or avoidance goals; 24 items; each item is rated on a 4-point scale from 1 (not at all true for me) to 4 (very true for me).
|
At baseline (T0)
|
Somatosensory amplification - 'Somatosensory Amplification Scale' (SSAS)
Time Frame: At baseline (T0)
|
Self-report questionnaire to assess amount of somatosensory amplification tendencies; 10 items; items are rated on a 5-point scale from 1 (not at all true) - 5 (extremely true); total scores range from 10-50 with higher scores indicating more somatosensory amplification.
|
At baseline (T0)
|
Psychopathology - 'Structured Clinical Interview for DSM-5, Clinician Version' (SCID-5-CV)
Time Frame: At screening
|
Expert-rated semi-structured interview to assess DSM-5 diagnoses.
|
At screening
|
Mental well-being - 'Short Warwick-Edinburgh Mental Wellbeing Scale' (SWEMWBS)
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Self-report questionnaire to assess mental well-being by 7 statements about thoughts and feelings using 5 response options, total scores range from 7-35 with higher scores reflecting a higher level of mental well-being.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Depression and anxiety - 'Patient-Healthcare-Questionnaire' (PHQ-4)
Time Frame: During follow-up [9 months]
|
Self-report measure comprising 4 items that assess core symptoms/signs of depression and anxiety.
Two items assess depression; two items assess anxiety, all by means of a four level Likert scale (0-3), so that total scores for each subscale range from 0-6.
A score of 3 or greater on the depression subscale indicates a higher probability of symptoms of depression; a score of 3 or greater on the anxiety subscale indicates a higher probability of symptoms of anxiety.
|
During follow-up [9 months]
|
Subjective impairment - adaptation of 'Pain Disability Index' (PDI)
Time Frame: At baseline (T0), one week post baseline (T1), five weeks post baseline (T5), and 13 weeks post baseline at primary endpoint (T9)
|
Self-report questionnaire to assess illness burden; 7 items; each item rated on a 0 (no disability)-10(maximum disability) standardized numerical analogue scale; total scores range from 0-70 with higher scores indicating more pronounced disability.
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At baseline (T0), one week post baseline (T1), five weeks post baseline (T5), and 13 weeks post baseline at primary endpoint (T9)
|
Substance Use
Time Frame: One week post baseline (T1), five weeks post baseline (T5), nine weeks post baseline (T7), and 13 weeks post baseline at primary endpoint (T9)
|
Assesses the consumption (volume and frequency) of nicotine, caffeine, alcohol, pain medication, tranquilizers, or recreational drugs.
|
One week post baseline (T1), five weeks post baseline (T5), nine weeks post baseline (T7), and 13 weeks post baseline at primary endpoint (T9)
|
Warmth & Competence
Time Frame: At baseline (T0), five week post baseline (T5), and 13 weeks post baseline at primary endpoint (T9)
|
Perceived warmth and competence from both the assessor's perspective (11 items, 0 (not at all) to 5 (very much)) and participants' perspectives (12 items, 0 (not at all) to 5 (very much)) will be assessed.
Higher scores indicate higher ratings of warmth and competence.
|
At baseline (T0), five week post baseline (T5), and 13 weeks post baseline at primary endpoint (T9)
|
Adverse events
Time Frame: Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Interview-based measure assessing adverse events, followed by an expert-rating of the intensity and description of the adverse events (1-5) and causal relation to treatment (1-6).
Higher scores indicate more and/or a higher intensity of adverse events.
|
Weekly during run-in and (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Suspicions about treatment - 'Generic rating scale for treatment experiences - end' (GEEEend)
Time Frame: 13 weeks post baseline at primary endpoint (T9)
|
Single item that asks participants to indicate whether they believe they discontinued or remained on their initial medication.
Optional item of the 'Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects' (GEEE).
|
13 weeks post baseline at primary endpoint (T9)
|
Illness rationale of Major Depressive Disorder:
Time Frame: At baseline (T0)
|
Single item that asks participants to rate whether they perceive their depressive disorder as a biologically or a psychologically caused illness on a single item ranging from 0 (biologically caused) to 10 (psychologically caused).
|
At baseline (T0)
|
Blood serum level of antidepressant medication
Time Frame: Exactly 7 days after baseline (T1) and at 13 weeks post baseline at primary endpoint (T9)
|
Assessed via blood analysis.
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Exactly 7 days after baseline (T1) and at 13 weeks post baseline at primary endpoint (T9)
|
Current treatment effects - 'Generic rating scale for treatment effects' (GEEEact)
Time Frame: Weekly after run-in and during (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
The Generic rating scale for treatment effects is one of three subscales of the 'Generic rating scale for previous treatment experiences, treatment expectations, and treatment effects' (GEEE).
The subscale 'Generic rating scale for treatment effects' consists of three items that assess current treatment effects, i.e., effects of antidepressant discontinuation or continuation, on a numeric rating scale with eleven response options (0-10) each; total scores range from 0-30 with higher scores indicating more pronounced effects of antidepressant discontinuation.
|
Weekly after run-in and during (dis-)continuation phase [5 weeks]; biweekly during monitoring phase [8 weeks]; follow-up [9 months]
|
Psychophysiological Stress - 'Perceived Stress Scale' (PSS-10)
Time Frame: At baseline (T0)
|
Self-reported measure of subjective stress, including 10 items with 5 rating categories (0-4), total scores range between 0-40 with higher scores indicating more pronounced stress.
|
At baseline (T0)
|
Anxiety vs. depression - 'State-Trait-Anxiety-Depression-Inventory' (STADI)
Time Frame: At baseline (T0)
|
Self-report questionnaire as indicator of state and trait anxiety and depression, divided in 2 sections (state vs. trait) consisting of 20 statements with 4 response options (1-4), respectively.
Total scores per scale range between 20 and 80 with higher sum scores indicating higher state/trait anxiety or depression.
Trait scale measured at baseline only.
|
At baseline (T0)
|
Discontinuation symptom load during prior discontinuation - 'Discontinuation Related Signs and Symptoms Scale' (DESSpast)
Time Frame: At baseline (T0)
|
The Discontinuation Related Signs and Symptoms Scale is a self-report questionnaire to assess discontinuation symptoms, incorporating 43 discontinuation symptoms of antidepressants with intensity ratings ranging from 0 (not present) - 3 (severe) each.
Total sum score ranges from 0-129 with higher scores indicating more pronounced discontinuation symptoms.
|
At baseline (T0)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yvonne Nestoriuc, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
- Principal Investigator: Tilo Kircher, Prof. Dr., Philipps University Marburg Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PV7151
- CRC 289 Project A15 (Other Grant/Funding Number: DFG Deutsche Forschungsgemeinschaft)
- U1111-1271-7231 (Other Identifier: Universal Trial Number (UTN))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Santa Casa Medical SchoolFaculdade de Ciências Médicas da Santa Casa de São PauloUnknownDepressive SymptomsBrazil
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State University of New York at BuffaloCompletedDepressive Symptoms | Major Depressive Disorder, Recurrent, in RemissionUnited States
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University of TorontoKaiser Permanente; University of Colorado, BoulderCompletedDepressive Symptoms | Major Depressive Disorder, Recurrent, in RemissionUnited States
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University of PittsburghCompleted
Clinical Trials on Treatment 'discontinuation of antidepressant medication'
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McMaster UniversityCanadian Institutes of Health Research (CIHR); David Braley and Nancy Gordon... and other collaboratorsRecruitingPolypharmacy | Multi-morbidity | Medication Therapy ManagementCanada
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McMaster UniversityCanadian Institutes of Health Research (CIHR); David Braley and Nancy Gordon... and other collaboratorsRecruitingPolypharmacy | Multi-morbidity | Medication Therapy ManagementCanada
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McMaster UniversityCanadian Frailty Network; Labarge Optimal AgingTerminatedFrailty | Polypharmacy | Long-term CareCanada
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University of PennsylvaniaNational Institute of Mental Health (NIMH)Completed
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McMaster UniversityHealth Canada; David Braley and Nancy Gordon Chair in Family Medicine; RxISK; The...CompletedMedication Therapy Management | ComorbidityCanada
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Mayo ClinicPatient-Centered Outcomes Research InstituteCompleted
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Leiden University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentActive, not recruiting
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Utrecht Institute for Pharmaceutical SciencesUCB PharmaTerminated
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Fondazione Policlinico Universitario Agostino Gemelli...Fundacion Clinic per a la Recerca Biomédica; Newcastle University; University...RecruitingRheumatoid ArthritisItaly, Spain, United Kingdom
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)Active, not recruitingMetastatic Prostate Carcinoma | Stage IV Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage IVB Prostate Cancer AJCC v8 | Castration-Sensitive Prostate CarcinomaUnited States