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Trial record 24 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression

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ClinicalTrials.gov Identifier: NCT02772211
Recruitment Status : Unknown
Verified May 2016 by Dr. Revital Amiaz, Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Collaborators:
Teva Pharmaceuticals USA
Tel Aviv University
Information provided by (Responsible Party):
Dr. Revital Amiaz, Sheba Medical Center

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Drug: Ketamine Drug: D-cycloserine Drug: Placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: D-cycloserine
Participants in this group would receive 6 infusions of ketamine. Participants who demonstrate symptoms reduction following ketamine infusions would receive oral D-cycloserine, titrated slowly up to 1000mg/d over the next 8 weeks.
Drug: Ketamine

Patients will undergo 6 ketamine infusions within a 3-week period. Intravenous ketamine will be administrated by a senior anesthesiologist and under the supervision of a senior psychiatrist hence ensuring patient safety. The procedure will be explained in detail to each patient, and written consent will be obtained.

After a psychiatric and medical evaluation by a senior psychiatrist and a senior anesthesiologist, patients will be given ketamine infusion added on to their antidepressant therapy. A slow ketamine infusion of 0.5mg/kg over 40 minutes will be given to the patients. Patients will be monitored by the experienced staff which includes a senior anesthesiologist and a nurse as well as a psychiatrist who will be available nearby. All patients will be monitored continuously for heart rate and rhythm and oxygen saturation, and blood pressure will be measured at 10 minutes intervals.


Drug: D-cycloserine

Following completion of Ketamine infusions. patients in the experimental group will start receiving D-cycloserine pills titrated slowly up to 1000mg/d over the next 8 weeks [2] in the following manner:

  1. Week 4: Days 22-24 - 250mg/d, one pill per day Well-being assessment and adverse effect evaluation before drug elevation.
  2. Mid-week 4 to end of week 6: Days 25-42 - 500mg/d, two pills per day
  3. Week 7: Day 43-49 - 750mg/d, three pills per day
  4. Weeks 8-11: Days 50-77 - 1000mg/d four pills per day
Other Name: D-cycloserine, Cycloserine, DCS

Placebo Comparator: Placebo
Participants in this group would receive 6 infusions of ketamine. Participants who demonstrate symptoms reduction following ketamine infusions would receive oral Placebo pills, titrated slowly up to 1000mg/d over the next 8 weeks.
Drug: Ketamine

Patients will undergo 6 ketamine infusions within a 3-week period. Intravenous ketamine will be administrated by a senior anesthesiologist and under the supervision of a senior psychiatrist hence ensuring patient safety. The procedure will be explained in detail to each patient, and written consent will be obtained.

After a psychiatric and medical evaluation by a senior psychiatrist and a senior anesthesiologist, patients will be given ketamine infusion added on to their antidepressant therapy. A slow ketamine infusion of 0.5mg/kg over 40 minutes will be given to the patients. Patients will be monitored by the experienced staff which includes a senior anesthesiologist and a nurse as well as a psychiatrist who will be available nearby. All patients will be monitored continuously for heart rate and rhythm and oxygen saturation, and blood pressure will be measured at 10 minutes intervals.


Drug: Placebo

Following completion of Ketamine infusions. patients in the experimental group will start receiving placebo titrated slowly up to 1000mg/d over the next 8 weeks [2] in the following manner:

  1. Week 4: Days 22-24 - 250mg/d, one pill per day Well-being assessment and adverse effect evaluation before drug elevation.
  2. Mid-week 4 to end of week 6: Days 25-42 - 500mg/d, two pills per day
  3. Week 7: Day 43-49 - 750mg/d, three pills per day
  4. Weeks 8-11: Days 50-77 - 1000mg/d four pills per day




Primary Outcome Measures :
  1. Montgomery Asberg Depression Scale (MADRS) [ Time Frame: screening criteria, after third ketamine infusions ]
    A diagnostic questionnaire, measuring the severity of depressive episodes.


Other Outcome Measures:
  1. Hamilton depression Rating Scale [ Time Frame: 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 ]
    A diagnostic questionnaire, measuring the severity of depressive episodes.

  2. Clinical Global Severity Scale [ Time Frame: 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 ]
    A questionnaire, measuring the current global state of a person

  3. Clinical Global Improvement [ Time Frame: after third ketamine infusion, after sixth ketamine infusion, week 7, week 11, 2 months after study completion ]
    A questionnaire, measuring the improvement in clinical symptoms

  4. Hamilton Anxiety Scale [ Time Frame: 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 ]
  5. Toronto Alexithymia Scale [ Time Frame: 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 ]
  6. N-Back test [ Time Frame: 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 ]
    computerized tasks featuring neutral stimuli

  7. Verbal Fluency test [ Time Frame: 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 ]
    computerized tasks featuring neutral stimuli

  8. Stop signal test [ Time Frame: 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 ]
    computerized tasks featuring neutral stimuli

  9. ANTI [ Time Frame: 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 ]
    computerized tasks featuring neutral stimuli



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772211


Contacts
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Contact: Revital Amiaz, MD +972-542378757 revital.amiaz@sheba.health.gov.il

Locations
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Israel
Psychiatry Clinic - Sheba Medical Center
Ramat-Gan, Israel
Sponsors and Collaborators
Sheba Medical Center
Teva Pharmaceuticals USA
Tel Aviv University

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Responsible Party: Dr. Revital Amiaz, Doctor, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02772211     History of Changes
Other Study ID Numbers: 2853-15-SMC
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Cycloserine
Antibiotics, Antitubercular
Anti-Bacterial Agents
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antitubercular Agents
Antimetabolites