drugset / Trial / NCT02772211
D-cycloserine for Relapse Prevention Following Intravenous Ketamine in Treatment-resistant Depression
Phase 4
Unknown
60 enrolled
Sheba Medical Center
Tel Aviv University · collabTeva Pharmaceuticals USA · collab
RandomizedParallel-groupTriple-blindTreatment
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
Timeline
- Start
- 2016-06
- Primary completion
- 2016-12
- Completion
- 2017-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cycloserine | Small molecule | 1000 mg | — |
| Subject | Ketamine | Small molecule | 0.5 mg/kg | Intravenous |
Indications
No indication recorded.