Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression
NCT ID: NCT04234776
Last Updated: 2020-01-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE4
Total Enrollment
88 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-04-03
Study Completion Date
2021-04-03
Brief Summary
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The treatment of resistant depression should be optimized aiming at complete remission of symptoms, a complex condition due to several factors. Approximately 1/3 of patients with depressive disorders do not even respond to available antidepressants. Consequently, new molecules with robust action, fast effects and sustained improvement are currently being researched worldwide. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has emerged as a promising alternative due to its involvement in neurogenesis, synaptogenesis and consequent rapid improvement of depressive and suicidal symptoms with traditional intravenous (IV) use in sub dose (0.5 mg / kg). The therapeutic response of IV use has been short and requires monitoring in a hospital setting. There are no studies evaluating response to long-term ketamine use. Recent research has focused on identifying other routes of ketamine use such as intranasal and intramuscular (IM). The use of ketamine IM, despite the fact that there are few studies and small samples, can demonstrate efficacy in acute treatment and maintenance of depression, as well as low profile of side effects, greater accessibility potential, reduced costs and risks, patient comfort and possible expansion of resistant depression treatment capabilities in different settings.
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Detailed Description
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Compare the response of ketamine IM versus active control in treatment-resistant depression (TRD \[primary outcome\]) and find safety and tolerability of ketamine IM, evaluate changes in life quality, cognition and suicidal risk (secondary outcomes)
Conditions
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Depressive Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Subjects will receive IM ketamine or IM saline applications as randomized. Applications will occur three times a week. It will be 4 weeks of IM application (12 initial applications). Injections will occur into the subjects' glutes (0.75 mg / kg). The ketamine group will use 2 placebo tablets and the parallel group escitalopram 15 mg and aripiprazole 5 mg. Thereafter, participants will receive weekly ketamine doses over 6 months as maintenance treatment. Research members will be submitted to Structured Clinical Interview for the DSM for diagnostic categorization and will be evaluated from other scales. Vital signs will be checked continuously for a period of 2 hours with each infusion. Patients will be observed in a quiet, comfortable room and subjected to medical monitoring for 2 hours. They will leave the environment in the company of a competent adult.
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Rapid-acting antidepressant
Subjects eligible to participate in the study will receive IM ketamine and will use 2 placebo tablets as randomized.
Group Type
EXPERIMENTAL
Ketamine
Intervention Type
DRUG
(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
Cognition
Intervention Type
DIAGNOSTIC_TEST
Composite tools
Suicide risk
Intervention Type
OTHER
MADRS (10) and HAM-D (3)
Depression thoughts
Intervention Type
OTHER
EPD
Quality of life and disability
Intervention Type
OTHER
Quality of life and disability
Clinical and epidemiological factors
Intervention Type
OTHER
Variables and categories
Safety of ketamine IM
Intervention Type
DEVICE
Vital signs
Tolerability of ketamine IM
Intervention Type
OTHER
UKU-SERS, YOUNG, CADSS and BPRS-12.
Comparator
Subjects eligible to participate in the study will receive IM saline and will use escitalopram 15 mg and aripiprazole 5 mg as randomized
Group Type
ACTIVE_COMPARATOR
Ketamine
Intervention Type
DRUG
(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
Cognition
Intervention Type
DIAGNOSTIC_TEST
Composite tools
Suicide risk
Intervention Type
OTHER
MADRS (10) and HAM-D (3)
Depression thoughts
Intervention Type
OTHER
EPD
Quality of life and disability
Intervention Type
OTHER
Quality of life and disability
Clinical and epidemiological factors
Intervention Type
OTHER
Variables and categories
Safety of ketamine IM
Intervention Type
DEVICE
Vital signs
Tolerability of ketamine IM
Intervention Type
OTHER
UKU-SERS, YOUNG, CADSS and BPRS-12.
Interventions
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Ketamine
(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
Intervention Type
DRUG
Cognition
Composite tools
Intervention Type
DIAGNOSTIC_TEST
Suicide risk
MADRS (10) and HAM-D (3)
Intervention Type
OTHER
Depression thoughts
EPD
Intervention Type
OTHER
Quality of life and disability
Quality of life and disability
Intervention Type
OTHER
Clinical and epidemiological factors
Variables and categories
Intervention Type
OTHER
Safety of ketamine IM
Vital signs
Intervention Type
DEVICE
Tolerability of ketamine IM
UKU-SERS, YOUNG, CADSS and BPRS-12.
Intervention Type
OTHER
Other Intervention Names
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Active comparator (escitalopram plus aripiprazole)
Placebo
Eligibility Criteria
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Inclusion Criteria
1. Diagnosis of TRD, according to clinical evaluation and confirmed by SCID-IV (Structured Clinical Interview for the DSM);
2. Moderate to severe intensity of the disease;
3. 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,
4. Literate and able to understand the tasks requested;
5. With clinical comorbidities, however compensated;
6. Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form.
2. Moderate to severe intensity of the disease;
3. 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,
4. Literate and able to understand the tasks requested;
5. With clinical comorbidities, however compensated;
6. Patients and/or legal representatives should understand the nature of the study and sign the Informed Consent Form.
Exclusion Criteria
1. Imminent risk of suicide;
2. Patients with psychoactive substance dependence;
3. Intellectual deficit and psychotic symptoms;
4. Bipolar spectrum disorders and other primary psychiatric diagnoses;
5. Allergic to ketamine;
6. Glaucoma;
7. Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0;
8. Treatment with irreversible MAOI in two weeks prior to visit 0;
9. Fluoxetine treatment within 4 weeks prior to visit 0;
10. Treatment with others antidepressants;
11. Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0;
a. Lorazepam and zolpidem may be used;
12. Patients who become pregnant will be excluded from the study and referred for obstetric care.
2. Patients with psychoactive substance dependence;
3. Intellectual deficit and psychotic symptoms;
4. Bipolar spectrum disorders and other primary psychiatric diagnoses;
5. Allergic to ketamine;
6. Glaucoma;
7. Treatment with reversible MAOI (monoamine oxidase inhibitor) in the week prior to visit 0;
8. Treatment with irreversible MAOI in two weeks prior to visit 0;
9. Fluoxetine treatment within 4 weeks prior to visit 0;
10. Treatment with others antidepressants;
11. Treatment with antipsychotics, lithium, benzodiazepines or other psychotropic drugs within 7 days prior to visit 0;
a. Lorazepam and zolpidem may be used;
12. Patients who become pregnant will be excluded from the study and referred for obstetric care.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Sao Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Ricardo Alberto Moreno, M.D., Ph.D.
Study principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Ricardo A Moreno, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department and Institute of Psychiatry, University of Sao Paulo
Locations
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Núcleo de Pesquisas em Saúde Mental
Blumenau, Santa Catarina, Brazil
Site Status
Countries
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Brazil
References
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Reference Type
DERIVED
Other Identifiers
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rampty2805
Identifier Type: -
Identifier Source: org_study_id
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Action of Ketamine in Treatment-Resistant Depression
NCT01945047
COMPLETED
PHASE2/PHASE3
Ketamine Treatment Effects on Synaptic Plasticity in Depression
NCT04091971
COMPLETED
PHASE4
Efficacy of Repeated Ketamine Infusions for Treatment-resistant Depression
NCT02360280
COMPLETED
PHASE2
Repeated Neurocognitive Measurements in Depressed Patients
NCT05991232
NOT_YET_RECRUITING
PHASE1/PHASE2
The Impact of AMPA Receptor Blockade on Ketamine's Anti-Suicidal Effects
NCT05786066
RECRUITING
PHASE2
Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD
NCT03131050
COMPLETED
PHASE4
Ketamine Plus Lithium in Treatment-Resistant Depression
NCT01880593
COMPLETED
PHASE2
Repeated Neurocognitive Measurements in Depressed Patients
NCT04916548
COMPLETED
PHASE1/PHASE2
Effect of Lithium Versus Placebo in Adults With Treatment-Resistant Depression Who Are Receiving Ketamine
NCT03290963
WITHDRAWN
PHASE2