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.

Topic Treatment-Resistant Depression
Compound Placebo Ketamine
Country Israel
Visit trial
Status Unknown status
Results Published
Start date 01 June 2016
End date 01 January 2017
Chance of happening 0%
Phase Phase IV
Design Blinded
Type Interventional
Generation First
Participants 60
Sex All
Age 18- 74
Therapy No

Trial Details

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.

NCT Number NCT02772211

Sponsors & Collaborators

Sheba Medical Center
This company doesn't have a full profile yet, it is linked to a clinical trial.

Teva Pharmaceuticals USA
This company doesn't have a full profile yet, it is linked to a clinical trial.

Tel Aviv University
The Institute for Integrative Psychedelic Research at Tel Aviv University (IPR-TLV) aims to revolutionize mental health through the interdisciplinary study of psychedelics.

Measures Used

Montgomery-Asberg Depression Rating Scale
A ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.

Data attribution

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