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.
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 CenterThis 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 ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.