Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2007-04-30

Brief Summary

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The study aims to assess the effects of single dose and repeated weekly dosing of 50mg d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients. The study will also examine the effects of 50mg d-cycloserine on positive symptoms and negative symptoms, as well as assess tolerability and side-effects.

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Detailed Description

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This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects at weeks 1, 2, 3. 4, 5, 6, 7, 8 \& 10 of once-weekly oral D-cycloserine 50 mg added to a stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.

Specific aims:

1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
4. Assess the persistence of learned information in a no-treatment follow-up assessment at Week 10 in the D-cycloserine group compared to the placebo group.
5. Assess effects of weekly D-cycloserine dosing on positive \& negative symptoms at week 8 compared to placebo.
6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Conditions

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Schizophrenia

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

50 mg d-cycloserine

Group Type EXPERIMENTAL

d-cycloserine

Intervention Type DRUG

50mg dose d-cycloserine v placebo

Placebo

50 mg placebo

Group Type PLACEBO_COMPARATOR

d-cycloserine

Intervention Type DRUG

50mg dose d-cycloserine v placebo

Interventions

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d-cycloserine

50mg dose d-cycloserine v placebo

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No