Treatment Resistant Depression Clinical Trial
Official title:
D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression
This is a two-stage experiment; the first stage is an open label trial in which participants receive six intravenous (IV) treatments of ketamine. The second stage includes participants that responded to ketamine (i.e. reduction of 25% in their symptoms of depression, as measured by the Montgomery Asberg Depression Scale MADRS). The second stage is a double-blind, controlled clinical trial of D-cycloserine (DCS) vs. placebo, as maintenance treatment in patients who responded to ketamine treatment. The aim of the study is to determine whether 8 weeks of DCS maintenance therapy will prevent relapse of depressive symptoms following ketamine infusions
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | January 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients aged 18-75 meeting DSM-V criteria for moderate-severe depression (MADRS=25), who did not respond to two adequate antidepressant courses of treatment. Subjects will be required to continue on a stable dose of any psychotropic medication they are taking, for 8 weeks prior to ketamine infusion. Participants who respond to ketamine (reduction of 25% in symptoms) would be invited to participate in a second stage of the experiment, in which participants would consume DCS for 8 weeks (weeks 4-11). Exclusion Criteria: - Patients will be excluded if they have current or history of psychotic or dissociative symptoms, or severe personality disorder with psychosis or dissociative symptoms. Additional exclusion criteria will be a lifetime history of psychotic mania, a substance abuse or use of alcohol. Medical exclusion criteria will include - uncontrolled elevated blood pressure, non-sinus rhythm, unstable ischemic heart disease, uncorrected hyper thyroidism, and for women, pregnancy or the initiation of female hormonal treatment <3 months. Before ketamine treatment women of childbearing age will be required to use a medical accepted contraceptive or abstain from sexual activity. In addition patients will be excluded if they suffer from chronic renal failure, epilepsy, organic brain disorder or neurological or an unstable medical condition. Due to neurotoxicity and convulsions, patients will be prohibited to consume alcohol. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Psychiatry Clinic - Sheba Medical Center | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center | Tel Aviv University, Teva Pharmaceuticals USA |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hamilton depression Rating Scale | A diagnostic questionnaire, measuring the severity of depressive episodes. | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | Clinical Global Severity Scale | A questionnaire, measuring the current global state of a person | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | Clinical Global Improvement | A questionnaire, measuring the improvement in clinical symptoms | after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | Hamilton Anxiety Scale | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No | |
Other | Toronto Alexithymia Scale | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | ||
Other | N-Back test | computerized tasks featuring neutral stimuli | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | Verbal Fluency test | computerized tasks featuring neutral stimuli | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | Stop signal test | computerized tasks featuring neutral stimuli | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Other | ANTI | computerized tasks featuring neutral stimuli | Up to ten days pre first ketamine administration, after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion | No |
Primary | Montgomery Asberg Depression Scale (MADRS) | A diagnostic questionnaire, measuring the severity of depressive episodes. | screening criteria, after third ketamine infusions | No |
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