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Once Weekly D-cycloserine for Schizophrenia

NCT ID: NCT00964041

Last Updated: 2013-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-06-30

Brief Summary

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This is a parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 4, \& 8 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in adult outpatients with schizophrenia.

Detailed Description

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In a previous placebo-controlled trial, investigators demonstrated significant improvement of negative symptoms with once-weekly D-cycloserine treatment. In addition, investigators found significant improvement of memory consolidation following the first dose; however, the effect on memory consolidation was lost after several weeks. The "practice effect" of weekly measurement of memory consolidation using repeated administration of the Logical Memory Test may have resulted in a "ceiling effect" which would obscure drug/placebo differences. In the current study, investigators propose to administer the Logical Memory Test at four-week intervals (weeks 1, 4 and 8) to avoid the ceiling effect. Additionally a measurement will be added of negative symptoms at week 4 to better characterize the time course of negative symptom improvement.

Hypotheses:

1. Assess the effects of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.
2. Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 \& 8.
3. Assess the effects of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery at week 8 compared to placebo.
4. Assess effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 \& 8 compared to placebo.
5. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.

Conditions

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Schizophrenia

Keywords

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Cognitive Impairment Neuroplasticity D-cycloserine N-methyl-D-aspartate (NMDA) Anti-Bacterial Agents Mental Disorders Psychotic Disorders Antitubercular Agents Schizophrenia and Disorders with Psychotic Features Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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D-cycloserine

Participants will receive D-cycloserine weekly, one hour before any assessments, for eight weeks.

Group Type EXPERIMENTAL

D-cycloserine

Intervention Type DRUG

50 mg by mouth weekly, one hour before assessments, for eight weeks.

Placebo

Participants will receive placebo weekly, one hour before any assessments, for eight weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.

Interventions

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D-cycloserine

50 mg by mouth weekly, one hour before assessments, for eight weeks.

Intervention Type DRUG

Placebo

Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.

Intervention Type DRUG

Other Intervention Names

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Seromycin Cycloserine

Eligibility Criteria

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Inclusion Criteria

1. Male or female
2. Age 18-65 years
3. Diagnosis of schizophrenia or schizoaffective disorder, depressed type
4. Stable dose of antipsychotic for at least 4 weeks.
5. Able to provide informed consent
6. Able to complete a cognitive battery

Exclusion Criteria

1. Current treatment with clozapine
2. Dementia
3. Seizure disorder
4. Unstable medical illness
5. Active substance abuse
6. Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.
7. Severe renal insufficiency (Serum creatinine \> 1.5 mg/dL)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Donald C. Goff, MD

Director of the Schizophrenia Clinical and Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Donald C Goff, M.D.

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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P50MH060450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DATR A3-NSC

Identifier Type: -

Identifier Source: secondary_id

2009-P-001341

Identifier Type: -

Identifier Source: org_study_id