- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04234776
Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression (KETProject)
Intramuscular Ketamine Versus Escitalopram and Aripiprazole in Acute and Maintenance Treatment of Patients With Treatment-resistant Depression
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Santa Catarina
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Blumenau, Santa Catarina, Brazil, 89.020-070
- Núcleo de Pesquisas em Saúde Mental
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of TRD, according to clinical evaluation and confirmed by SCID-IV (Structured Clinical Interview for the DSM);
- Moderate to severe intensity of the disease;
Female patients in fertile conditions should be using a clinically accepted contraceptive method (oral contraceptive and/or condom);
a. Blood test will be requested at the diagnostic stage and in case of clinical doubt as to the patient's gestational status,
- Literate and able to understand the tasks requested;
- With clinical comorbidities, however compensated;
- Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form.
Exclusion Criteria:
- Imminent risk of suicide;
- Patients with psychoactive substance dependence;
- Intellectual deficit and psychotic symptoms;
- Bipolar spectrum disorders and other primary psychiatric diagnoses;
- Allergic to ketamine;
- Glaucoma;
- Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0;
- Treatment with irreversible MAOI in two weeks prior to visit 0;
- Fluoxetine treatment within 4 weeks prior to visit 0;
- Treatment with others antidepressants;
Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0;
a. Lorazepam and zolpidem may be used;
- Patients who become pregnant will be excluded from the study and referred for obstetric care.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rapid-acting antidepressant
Subjects eligible to participate in the study will receive IM ketamine and will use 2 placebo tablets as randomized.
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(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
Other Names:
Composite tools
MADRS (10) and HAM-D (3)
EPD
Quality of life and disability
Variables and categories
Vital signs
UKU-SERS, YOUNG, CADSS and BPRS-12.
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Active Comparator: Comparator
Subjects eligible to participate in the study will receive IM saline and will use escitalopram 15 mg and aripiprazole 5 mg as randomized
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(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
Other Names:
Composite tools
MADRS (10) and HAM-D (3)
EPD
Quality of life and disability
Variables and categories
Vital signs
UKU-SERS, YOUNG, CADSS and BPRS-12.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms
Time Frame: 3 times a week in once month (Phase II)
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Montomery-Åsberg Depression Rating Scale ([0-60] higher scores: worse outcome).
No improvement: MADRS ≤ 25% Partial response: MADRS ≥ 25% and < 50% Response: MADRS ≥ 50% Remission: MADRS ≤10
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3 times a week in once month (Phase II)
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Change in depressive symptoms
Time Frame: Once a week in six months (Phase III)
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Montgomery-Åsberg Depression Rating Scale ([0-60] higher scores: worse outcome). Recovery: Maintenance ≥ 6-8 months Relapse: Full return of symptoms once remission has occurred or worsening ≤ 75% with lower percentage of improvement (HAM-D inclusion criteria) |
Once a week in six months (Phase III)
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Change in depressive symptoms
Time Frame: Once a week in once month (Phase IV)
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Montgomery-Åsberg Depression Rating Scale ([0-60] higher scores: worse outcome). Relapse: Full return of symptoms once remission has occurred or worsening ≤ 75% with lower percentage of improvement (HAM-D inclusion criteria). |
Once a week in once month (Phase IV)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression symptoms
Time Frame: Through study completion, an average of 1 year.
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Hamiltom Depression Ratins Scale (HAM-D [0-50] higher scores: worse outcome).
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Through study completion, an average of 1 year.
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Clinical impressions-S
Time Frame: Through study completion, an average of 1 year.
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Clinical Global Impression Scale (CGI [0-7] higher scores: worse outcome).
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Through study completion, an average of 1 year.
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Clinical impressions-I
Time Frame: Through study completion, an average of 1 year.
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Clinical Global Impression Scale (CGI [0-7] higher scores: worse outcome).
|
Through study completion, an average of 1 year.
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Electrocardiographic monitoring
Time Frame: 3 times a week in once month (Fase II) and once a week in six months (Phase III)
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P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval and U wave Rhythm (irregular rhythm: worse outcome).
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3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Blood Pressure (BP [mmHg]).
Time Frame: 3 times a week in once month (Fase II) and once a week in six months (Phase III)
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BP low <90/60 (systolic/diastolic) mmHg and high >140/90 mmHg ( (systolic/diastolic).
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3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Heart rate (HR [bpm]).
Time Frame: 3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Anormal HR <60 bpm or >100 bpm.
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3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Digital pulse oximetry (%).
Time Frame: 3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Low oxygen saturation <95%.
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3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Respiratory rate (RR [cycles/min])
Time Frame: 3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Anormal RR <10 cycles/min or >20 cycles/min.
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3 times a week in once month (Fase II) and once a week in six months (Phase III)
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Suicide risk 1
Time Frame: Through study completion, an average of 1 year.
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Montgomery-Åsberg Depression Rating Scale (item 10 [0-6] higher scores: worse outcome).
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Through study completion, an average of 1 year.
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Suicide risk 2
Time Frame: Through study completion, an average of 1 year.
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Hamilton Depression Rating Scale (item 3 [0-4] higher scores: worse outcome).
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Through study completion, an average of 1 year.
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General side effects
Time Frame: 3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Ugvalg for Kliniske Undersgelser-Side Effect Rating Scale (UKU-SERS [48 specific symptoms).
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3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Hypo/maniac symptoms
Time Frame: 3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Young Mania Rating Scale (YOUNG [0-58] higher scores: worse outcome).
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3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Dissociative symptoms
Time Frame: 3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Clinician-Administered Dissociative State Scale (CADSS [0-108] higher scores: worse outcome)
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3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Psychotic symptoms
Time Frame: 3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Brief Psychiatric Rating Scale (item 12 [0-6] higher scores: worse outcome).
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3 times a week in once month (Phase II) and once a week in six months (Phase III)
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Depression thoughts
Time Frame: Through study completion, an average of 1 year.
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Depression Thoughts Scale (EPD [1-78] higher scores: worse outcome)
|
Through study completion, an average of 1 year.
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Stimate intelligence quocient
Time Frame: Through study completion, an average of 1 year.
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Wechsler Abreviated Scale of Intelligence (WASI [70-160 percentille] higher scores: better outcomes).
|
Through study completion, an average of 1 year.
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Intelligence quocient
Time Frame: Through study completion, an average of 1 year.
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Wechsler Scale of Intelligence (WAIS III [70-155 percentille] higher scores: better outcomes).
|
Through study completion, an average of 1 year.
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Attention
Time Frame: Through study completion, an average of 1 year.
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Trial Making Test (5-95 percentille, higher scores: better outcomes).
|
Through study completion, an average of 1 year.
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Memory
Time Frame: Through study completion, an average of 1 year.
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Rey figures (10-100 percentille, higher scores: better outcomes)
|
Through study completion, an average of 1 year.
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Executive functions 1
Time Frame: Through study completion, an average of 1 year.
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Wisconsin Test (50->80 score, higher scores: better outcomes).
|
Through study completion, an average of 1 year.
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Executive functions 2
Time Frame: Through study completion, an average of 1 year.
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Stroop Color Word Test (5-95 percentille, higher scores: better outcomes)
|
Through study completion, an average of 1 year.
|
Verbal fluency 1
Time Frame: Through study completion, an average of 1 year.
|
Verbal Fluency Test (FAS [10-90 percentille], higher scores: better outcomes))
|
Through study completion, an average of 1 year.
|
Verbal fluency 2
Time Frame: Through study completion, an average of 1 year.
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The Rey Auditory-Verbal Learning Test (RAVLT [5-95 percentille], higher scores: better outcomes).
|
Through study completion, an average of 1 year.
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Functional recovery 1
Time Frame: Through study completion, an average of 1 year.
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World Health Organization Quality of Life (WHOQOL-brief [4 domains, 26 questions higher scores: better outcome]).
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Through study completion, an average of 1 year.
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Functional recovery 2
Time Frame: Through study completion, an average of 1 year.
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Sheehan Disability Scale (SDS [0-30] higher scores: worse outcome).
|
Through study completion, an average of 1 year.
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Body Mass Index (BMI)
Time Frame: Through study completion, an average of 1 year.
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Weight and height (kg/m2).
|
Through study completion, an average of 1 year.
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Clinical and psychiatric features 1
Time Frame: Through study completion, an average of 1 year.
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Disease intensity (HAM-D [% of patients], moderate or severe)
|
Through study completion, an average of 1 year.
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Clinical and psychiatric features 2
Time Frame: Through study completion, an average of 1 year.
|
Number of episodes (questionnaire [incidence])
|
Through study completion, an average of 1 year.
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Clinical and psychiatric features 3
Time Frame: Through study completion, an average of 1 year.
|
Current episode duration (questionnaire [years])
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 4
Time Frame: Through study completion, an average of 1 year.
|
Suicide attempts (questionnaire [% of pacients])
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 5
Time Frame: Through study completion, an average of 1 year.
|
History of physical abuse (questionnaire [% of pacients])
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 6
Time Frame: Through study completion, an average of 1 year.
|
History of sexual abuse (questionnaire [% of pacients])
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 7
Time Frame: Through study completion, an average of 1 year.
|
Psychiatric hospitalizations (questionnaire [% of pacients])
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 8
Time Frame: Through study completion, an average of 1 year.
|
Clinical comorbidities (questionnaire [% of patients]).
|
Through study completion, an average of 1 year.
|
Clinical and psychiatric features 9
Time Frame: Through study completion, an average of 1 year.
|
Family history of depression (questionnaire [% of patients])
|
Through study completion, an average of 1 year.
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Clinical and psychiatric features 10
Time Frame: Through study completion, an average of 1 year.
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Family history of bipolar disorders (questionnaire [% of patients)
|
Through study completion, an average of 1 year.
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Clinical and psychiatric features 11
Time Frame: Through study completion, an average of 1 year.
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Family history of other mental disorders (questionnaire [% of patients]).
|
Through study completion, an average of 1 year.
|
Epidemiological features 1
Time Frame: Through study completion, an average of 1 year.
|
Age (questionnaire [years]).
|
Through study completion, an average of 1 year.
|
Epidemiological features 2
Time Frame: Through study completion, an average of 1 year.
|
Gender (questionnaire [% of patients]; male/female)
|
Through study completion, an average of 1 year.
|
Epidemiological features 3
Time Frame: Through study completion, an average of 1 year.
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Marital status (questionnaire [% of patients] single, married, separated, divorced or widower).
|
Through study completion, an average of 1 year.
|
Epidemiological features 4
Time Frame: Through study completion, an average of 1 year.
|
Ethnicity (questionnaire [% of patients])
|
Through study completion, an average of 1 year.
|
Epidemiological features 5
Time Frame: Through study completion, an average of 1 year.
|
Religion (questionnaire [% of patients] protestant, pentecostal or neopentecostal, spiritism, afro-brazilian, no religion or atheism and others]).
|
Through study completion, an average of 1 year.
|
Epidemiological features 6
Time Frame: Through study completion, an average of 1 year.
|
Occupation (questionnaire [% of patients])
|
Through study completion, an average of 1 year.
|
Epidemiological features 7
Time Frame: Through study completion, an average of 1 year.
|
Education (questionnaire [years])
|
Through study completion, an average of 1 year.
|
Epidemiological features 8
Time Frame: Through study completion, an average of 1 year.
|
Individual income (questionnaire [dollars]).
|
Through study completion, an average of 1 year.
|
Epidemiological features 9
Time Frame: Through study completion, an average of 1 year.
|
Family income (questionnaire [dollars]).
|
Through study completion, an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ricardo A Moreno, MD, PhD, Department and Institute of Psychiatry, University of Sao Paulo
Publications and helpful links
General Publications
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Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive 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
- Antidepressive Agents, Second-Generation
- Ketamine
- Aripiprazole
- Citalopram
Other Study ID Numbers
- rampty2805
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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