Effects of Weekly Dosing of D-Cycloserine on Cognitive Function in Individuals With Schizophrenia
Information source: Massachusetts General Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: d-cycloserine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Massachusetts General Hospital Official(s) and/or principal investigator(s):
Donald C Goff, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
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.
Clinical Details
Official title: Effects of Weekly Dosing of D-Cycloserine on Cognitive Function in Individuals
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Main Outcome Measure: The change from baseline to week 8 on the SANS total score and on a composite cognitive score.
Secondary outcome: comparisons of treatment effects on the Positive Syndrome Subscale of the PANSS and CGI global improvement score at week 8change from baseline at the first repeat administration of the Logical Memory Test (immediate recall tested at week 1 and delayed recall tested at week 2)
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Additional Information
Starting date: July 2004
Ending date: April 2007
Last updated: December 14, 2007
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