Trial record 42 of 120 for:    CYCLOSERINE OR SEROMYCIN

D-cycloserine for Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00408031
Recruitment Status : Completed
First Posted : December 5, 2006
Last Update Posted : August 3, 2012
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Heresco-Levi Uriel, Herzog Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: D-cycloserine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: N-methyl-D-aspartate Receptor (NMDAR)-Based Pharmacotherapy With D-cycloserine for Treatment-resistant Major Depressive Disorder
Study Start Date : January 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cycloserine

Arm Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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 ]
  2. Change in Hamilton Rating Scale for Anxiety (HAMA) scores. [ Time Frame: 6 weeks ]

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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:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00408031

Ezrath Nashim - Herzog Memorial Hospital & Community Clinics
Jerusalem, Israel
Ezrath Nashim - Herzog Memorial Hospital
Jerusalem, Israel
Sponsors and Collaborators
Herzog Hospital
National Alliance for Research on Schizophrenia and Depression
Principal Investigator: Uriel Heresco-Levy, M.D. Ezrath Nashim - Herzog Memorial Hospital

Responsible Party: Heresco-Levi Uriel, Princepal Investigator, Herzog Hospital Identifier: NCT00408031     History of Changes
Obsolete Identifiers: NCT00781014
Other Study ID Numbers: Heresco 4 CTIL
Herzog - protocol 5372
First Posted: December 5, 2006    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012

Keywords provided by Heresco-Levi Uriel, Herzog Hospital:
Major depressive disorder
NMDA receptor

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action