Once Weekly D-cycloserine for Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00964041
• Other study ID #: 2009-P-001341
• Secondary ID: P50MH060450DATR
• Status: Withdrawn
• Phase: Phase 4
• First received: August 20, 2009
• Last updated: November 19, 2013
• Start date: July 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• D-cycloserine
50 mg by mouth weekly, one hour before assessments, for eight weeks.
• Placebo
Placebo by mouth, weekly, one hour before any assessments, each week for eight weeks.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of repeated weekly dosing of D-cycloserine on performance on a standard cognitive battery.		Baseline (Week 0) and End of Study (Week 8)	No
Secondary	Effects of weekly D-cycloserine dosing on negative symptoms at weeks 4 & 8 compared to placebo.		Baseline (Week 0) and End of Study (Week 8)	No
Secondary	Effect of a single dose of D-cycloserine 50 mg on memory consolidation as measured by the Logical Memory Test compared to placebo.		Same Day (Single Dose - Week 1)	No
Secondary	Assess the persistence of once-weekly D-cycloserine effects on memory consolidation measured at weeks 4 & 8.		Week 4 and Week 8	No
Secondary	Assess tolerability and side effects of weekly D-cycloserine compared to placebo		Weekly measurements for 8 weeks	Yes