- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01488266
Aripiprazole Augmentation Versus Switching to Different Class of Antidepressants in Major Depressive Disorder
Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Most guidelines have suggested that those nonresponders or partial responders should be considered for a switch, combination or augmentation of treatment. Traditional augmentation agents, lithium, triiodothyronine (T3), buspirone, dopamine agonists, and stimulants have been commonly used for this patient population with limited supporting data. Recently, augmentation of atypical antipsychotics with antidepressant therapy has become a more commonly accepted treatment practice. This strategy has proven to be useful for enhancement of antidepressant effect, showing increased remission rates and early treatment effects on core depressive symptoms, and comorbid symptoms as well as antidepressant- mediated side effects (e.g., sexual dysfunction). Although, we have some limited treatment options to treat such patients as described above, it is not clear which treatment option would be best or acceptable for those patients in clinical practice yet.
Among above augmentation agents, aripiprazole is the first drug approved by U.S. FDA. as an augmentation therapy to antidepressants in the treatment of patients with MDD showing imminent efficacy and reliable safety profile through adequately-powered well-designed controlled clinical trials.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Seoul, Korea, Republic of
- Korean Univ Ansan Hospital; Bucheon St.Mary Hospital; DonggukUniv Gyeongju Hospital; Catholic University of Korea St. Paul's Hospital
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Taipei, Taiwan
- Chang Gung Memorial Hospital; Kaohsiung Medical University Chung-ho Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients who are older than 20 years of age have a diagnosis of MDD without psychotic features, as defined by DSM-IV-TR.
- Patients have to report an inadequate response to a current antidepressant treatment. Inadequate response to antidepressant is defined as: total score of HDRS-17 is more than 14), despite adequate dose of current antidepressant treatment for at least 6 weeks in the current episode(co-administered with ATRQ)
- Classification of antidepressants which can be included in the study(list for suggestion): Escitalopram 10~20mg/day, fluoxetine 20~40mg/day,paroxetine controlled release(CR) 25~62.5mg or paroxetine 20~40mg, sertraline 100~150mg,bupropion XL(SR) 150~300mg, mirtazapine 15~45mg,venlafaxine immediate or extended release(IR or ER) 112.5~225mg/day, duloxetine 60mg [same criteria for generic medications as brand drugs]
Exclusion Criteria:
- Those who are first episode, drug naive MDD subjects
- Those who have a current Axis I diagnosis of delirium, dementia, amnestic or other cognitive disorder, schizophrenia or other psychotic disorder, bipolar 1 or 2 disorder, eating disorder, obsessive-compulsive disorder, panic disorder, or posttraumatic stress disorder
- Those who have a clinically significant current Axis 2 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder
- Those who experience hallucinations, delusion, or any psychotic symptomatology in the current depressive episode
- Those who have met DSM-IV-TR criteria for any significant substance use disorder within the past 12 months (except nicotine)
- Those who have known allergy,hypersensitivity or previous unresponsiveness to aripiprazole or known intolerance to other study medications
- Those who have had cognitive-behavioral therapy or other psychotherapy, or they have the potential need to be treated with them during the study periods
- Those who are complicated with serious medical problem, such as severe renal, hepatic dysfunction, cardiovascular, lung, gastrointestinal, endocrine, nervous, infectious disease, or neoblastic, metabolic disease
- Those who have shown previous unresponsiveness to adequate antidepressant trials more than 2 episodes or with 3 or more antidepressant treatments
- Those who have chronic liver or renal disease
- Those who are pregnant or brest-feeding
- Those who have participated in a clinical trial with aripiprazole or any other investigational product within the past month(include randomized, double-blind, placebo-controlled or open-label study; but chart review,observational study can be enrolled)
- Those who had a history of thyroid pathology, neuroleptic malignant syndrome, or serotonin syndrome
- Those who have received adjunctive antipsychotic plus antidepressant for more than 3 weeks during the current episode
- Those who have received electroconvulsive therapy for the current episode
- Those who have shown an inadequate response to previous ECT in any episode
- Those who have a suicidal risk
- Those who are likely to require prohibited concomitant therapy during the trial
- Those who have received treatment with a monoamine oxidase inhibitor within 2 weeks prior to enrollment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: aripiprazole augmentation
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patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response.
Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.
Other Names:
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Active Comparator: different class of antidepressant
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Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience).
Dose increase is permitted until the first 2 weeks of the study.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total score of MADRS
Time Frame: From baseline to end of treatment
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MADRS: montgomery Asberg Depression Rating Scale
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From baseline to end of treatment
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Response rate
Time Frame: at 2 weeks
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response rate is defined as a reduction in MADRS total score of at least 50% relative to the beginning of the randomized phase (baseline)
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at 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate
Time Frame: at week 2,4 and 6
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at week 2,4 and 6
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Remission rate
Time Frame: at week 2,4and 6
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remission rate is defined as an absolute MADRS total score of ≤10 at the end of treatment
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at week 2,4and 6
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Change of total score of HDRS-17
Time Frame: from baseline to end of treatment
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HDRS-17: Hamilton Depression Rating Scale-17 item
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from baseline to end of treatment
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Change of total score of CGI-S
Time Frame: from baseline to end of treatment
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CGI-S: Clinical Global Impression-Severity Score
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from baseline to end of treatment
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Change of total score of IFS
Time Frame: from baseline to end of treatment
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IFS: Iowa Fatigue Scale
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from baseline to end of treatment
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Change of total score of SDS
Time Frame: from baseline to end of treatment
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SDS: Sheehan Disability Scale
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from baseline to end of treatment
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Patients' ratio who have have scored 1 or 2 in the score of CGI-Improvement
Time Frame: at the end of treatment
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CGI-I: Clinical Global Impression-Improvement Score
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at the end of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Changsu Han, MD,PhD, MHS, Korea Univ Ansan Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Anti-Anxiety Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Cytochrome P-450 CYP2D6 Inhibitors
- Serotonin 5-HT3 Receptor Antagonists
- Dopamine Uptake Inhibitors
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Aripiprazole
- Sertraline
- Duloxetine Hydrochloride
- Citalopram
- Paroxetine
- Bupropion
- Venlafaxine Hydrochloride
- Mirtazapine
- Fluoxetine
- Milnacipran
- Antidepressive Agents
Other Study ID Numbers
- CASCADE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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