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

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 |

Arm | Intervention/treatment |
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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.
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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:
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.
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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:
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- Montgomery Asberg Depression Scale (MADRS) [ Time Frame: screening criteria, after third ketamine infusions ]A diagnostic questionnaire, measuring the severity of depressive episodes.
- 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.
- 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
- 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
- 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 ]
- 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 ]
- 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
- 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
- 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
- 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 |
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.

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
Contact: Revital Amiaz, MD | +972-542378757 | revital.amiaz@sheba.health.gov.il |
Israel | |
Psychiatry Clinic - Sheba Medical Center | |
Ramat-Gan, Israel |
Responsible Party: | Dr. Revital Amiaz, Doctor, Sheba Medical Center |
ClinicalTrials.gov Identifier: | NCT02772211 |
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 |
Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Behavioral Symptoms Mood Disorders Mental Disorders Cycloserine 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 Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Antimetabolites |