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

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00455702

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: d-cycloserine	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals

Resource links provided by NLM:

MedlinePlus related topics: Memory Schizophrenia

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Main Outcome Measure: The change from baseline to week 8 on the SANS total score and on a composite cognitive score. [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

comparisons of treatment effects on the Positive Syndrome Subscale of the PANSS and CGI global improvement score at week 8 [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
change 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) [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	July 2004
Study Completion Date:	September 2008
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: D-cycloserine 50 mg d-cycloserine	Drug: d-cycloserine 50mg dose d-cycloserine v placebo
Placebo Comparator: Placebo	Drug: d-cycloserine 50mg dose d-cycloserine v placebo

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:

Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning compared to placebo.
Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning at week 8 compared to placebo.
Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once a week 1 hour after medication administration compared to placebo.
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.
Assess effects of weekly D-cycloserine dosing on positive & negative symptoms at week 8 compared to placebo.
Assess tolerability and side effects of weekly D-cycloserine compared to placebo.
Assess the effects of d-cycloserine dosed weekly for seven weeks on reward responsiveness as measured with the response bias task compared with placebo.
Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of functioning.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Current treatment with clozapine
Dementia
Seizure disorder
Unstable medical illness
Active substance abuse
Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00455702

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Donald C Goff, M.D.

Massachusetts General Hospital

More Information

Publications:

Goff DC, Cather C, Gottlieb JD, Evins AE, Walsh J, Raeke L, Otto MW, Schoenfeld D, Green MF. Once-weekly D-cycloserine effects on negative symptoms and cognition in schizophrenia: an exploratory study. Schizophr Res. 2008 Dec;106(2-3):320-7. Epub 2008 Sep 16.

Responsible Party:	Donald Goff, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00455702 History of Changes
Other Study ID Numbers:	2005-P-001040
Study First Received:	April 2, 2007
Last Updated:	June 27, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

schizophrenia
cognition
d-cycloserine
memory

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Renal Agents
Antibiotics, Antitubercular
Anti-Bacterial Agents
Antitubercular Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012