Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

D-cycloserine for Major Depressive Disorder

This study has been completed.
Sponsor:
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital
ClinicalTrials.gov Identifier:
NCT00408031
First received: December 3, 2006
Last updated: August 2, 2012
Last verified: August 2012

December 3, 2006
August 2, 2012
January 2007
May 2010   (final data collection date for primary outcome measure)
  • Change in 24 item Hamilton Depression Rating Scale (HAMD) scores. Safety measures: UKU scale, vital signs assessments, laboratory parameters (SMA-20, CBC, UA) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Change in Hamilton Rating Scale for Anxiety (HAMA) scores. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00408031 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
D-cycloserine for Major Depressive Disorder
N-methyl-D-aspartate Receptor (NMDAR)-Based Pharmacotherapy With D-cycloserine for Treatment-resistant Major Depressive Disorder

For many depression patients treatment changes are required, including switching to another antidepressant and addition of a second antidepressant or a non-antidepressant agent ("augmentation"). The need to modify treatment is usually necessary because of partial or no response to first-line monotherapy or the failure to achieve remission although treatment response (improvement) has been obtained. These caveats of presently available antidepressant drugs highlight the need for innovative pharmacological treatment strategies. Recent data suggest that N-methyl-D-aspartate receptor (NMDAR) antagonists and partial agonists at the NMDAR-associated glycine binding site may represent a novel type of antidepressant medications. These types of compounds protect vulnerable neurons against a variety of insults, including stress-induced damage, and may serve to enhance and maintain normal synaptic connectivity. In animal models, these compounds mimic the effects of clinically effective antidepressants. Furthermore, down-regulation of the glycine site of the NMDAR was found to be a common feature of currently used antidepressant medications. D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated glycine site. Beneficial antidepressant effects have been reported with 500-1000 mg/day DCS regimens in depressed tuberculosis patients and recent preliminary findings suggest that DCS may also be beneficial in the treatment of major depressive disorder. The antidepressant effects of DCS seem to reflect consequences of its capacity to reduce NMDAR receptor function. In the present project, it is proposed to assess, using a random assignment, parallel-group, double blind, placebo controlled design, the effects of a NMDAR -antagonist DCS dose regimen, 250 --> 1000 mg/day for 6 wks, as adjuvant pharmacotherapy for treatment-resistant major depressive disorder patients. The study methodology includes the assessment of DCS effects upon symptoms profile, neurocognitive tests performance, amino acids serum levels, and brain electrophysiology parameters associated with the prepulse inhibition-startle response paradigm. It is hypothesized that significant beneficial DCS treatment effects will be registered.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Major Depressive Disorder
Drug: D-cycloserine
D-cycloserine (DCS , Seromycin) is a broad spectrum antibiotic, in use for over thirty years against tuberculosis, that acts as a partial agonist at the NMDAR-associated GLY site.
Experimental: 1
Randomization to 2 treatment groups. One group receives adjuvant treatment with D-cycloserine, up to 1 g/day. The second group receives adjuvant treatment with placebo, up to 1 g/day.
Intervention: Drug: D-cycloserine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • DSM-IV diagnosis of major depression .
  • HAMD scale score of ≥20 despite at least two adequate antidepressant treatment trials during the current episode.

Exclusion Criteria:

  • Underwent ECT treatment during the 3 months preceding the study.
  • Change in psychotropic medications doses during the 3 weeks preceding the study.
  • Concurrent unstable medical or neurological illness.
  • Patients are judged to be potentially violent towards themselves or others, or have a history of drug/alcohol abuse.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00408031
Heresco 4 CTIL, Herzog - protocol 5372
Not Provided
Heresco-Levi Uriel, Herzog Hospital
Herzog Hospital
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Uriel Heresco-Levy, M.D. Ezrath Nashim - Herzog Memorial Hospital
Herzog Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP