D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00963924

Purpose

This study seeks to examine the effects of D-cycloserine augmentation on cognitive remediation for patients diagnosed with schizophrenia. We will test the hypotheses that D-cycloserine will significantly improve cognitive performance, negative symptoms, and measures of functioning compared to placebo when combined with eight weeks of cognitive remediation. We expect that these effects will persist when assessed at six-month follow up.

Condition	Intervention
Schizophrenia	Drug: D-cycloserine Drug: Placebo Behavioral: Cognitive Remediation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Placebo-controlled Trial of D-cycloserine Augmentation of Cognitive Remediation in Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Mental Disorders Psychotic Disorders Schizophrenia

Drug Information available for: Cycloserine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) [ Time Frame: Weeks 0 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
Global Assessment Scale (GAS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: No ]
Heinrich Quality of Life Scale (QoL) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Weeks 0, 4 and 8, and Month 6 after cognitive remediation completion ] [ Designated as safety issue: No ]
Clinical Global Impression (CGI) [ Time Frame: Weeks 0 and 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: No ]
Side Effects Checklist (SEC) [ Time Frame: Weeks 0 - 8, and Month 6 after cogntive remediation completion ] [ Designated as safety issue: Yes ]
Brain Fitness Program Processing Speed Assessment [ Time Frame: Weeks 0, 1, 2, 4 and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	August 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: D-cycloserine Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.	Drug: D-cycloserine 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks. Other Name: Cycloserine Behavioral: Cognitive Remediation 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks. Other Name: Brain Fitness Program
Placebo Comparator: Placebo Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.	Drug: Placebo Placebo by mouth one hour before first cognitive remediation session each week for eight weeks. Behavioral: Cognitive Remediation 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks. Other Name: Brain Fitness Program

Detailed Description:

We propose to conduct an 8-week, placebo-controlled, double-blind, parallel-group trial of D-cycloserine augmentation of cognitive remediation in 80 stable schizophrenia outpatients. The primary outcome measure is change in performance on the MATRICS cognitive battery composite score after 8 weeks. Secondary outcome measures include a measure of processing speed assessed after weeks 1, 2, 4 & 8, and changes in negative symptoms and measures of functioning after 4 and 8 weeks. In addition, all outcome measures will be repeated at 6 months to assess persistence of benefit.

Hypotheses:

D-cycloserine will significantly improve cognitive performance as measured by the composite score on the MATRICS battery compared to placebo after 8 weeks of cognitive remediation.
D-cycloserine will significantly improve negative symptoms as measured by the SANS compared to placebo after 8 weeks when combined with cognitive remediation.
D-cycloserine will significantly improve measures of functioning (GAS, QoL and CGI) at 8 weeks compared to placebo when combined with cognitive remediation.
D-cycloserine effects on cognition, negative symptoms and functioning will persist compared to placebo when assessed at 6-month follow-up.

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
Able to perform the cognitive remediation exercises

Exclusion Criteria:

Current treatment with clozapine
Dementia
Seizure disorder
Unstable medical illness
Renal insufficiency measured as eGFR >60mg/dL/min
Active substance abuse: positive urine toxic screen
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: NCT00963924

Contacts

Contact: Timothy B. Creedon, B.A.	617-912-7864	tcreedon@partners.org
Contact: Lisa H. Raeke, M.A.	617-912-7840	lraeke@partners.org

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Lisa Raeke, MA 617-912-7840 lraeke@partners.org
Contact: Timothy Creedon, BA 617-912-7868 tcreedon@partners.org
Principal Investigator: Donald C. Goff, M.D.

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Donald C. Goff, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Donald C. Goff, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00963924 History of Changes
Other Study ID Numbers:	2008P002237, 5P50 MH060450, DATR A3-NSC
Study First Received:	August 20, 2009
Last Updated:	August 20, 2009
Health Authority:	United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by National Institute of Mental Health (NIMH):

Cognitive Impairment
Neuroplasticity
D-cycloserine
NMDA
Anti-Bacterial Agents

Mental Disorders
Psychotic Disorders
Antitubercular Agents
Schizophrenia and Disorders with Psychotic Features
Schizoaffective Disorder

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antitubercular Agents
Cycloserine
Anti-Bacterial Agents
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antibiotics, Antitubercular
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012