D-Serine for Enhancing Cognitive Retraining for the Treat... | NCT00237848

Studies
D-Serine for Enhancing Cognitive Retraining for the Treatment of Schizophrenia

NCT00237848

Sponsor

Yale University

Status

Completed

Last Update Posted

Jun 18, 2012Estimated

Enrollment

72Estimated

Phase

Phase 3

Conditions

Schizophrenia
Schizoaffective Disorder

Interventions

D-serine
Cognitive retraining

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01DA022495	U.S. NIH Grant/Contract		View source
103T-363

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Oct 7, 2005

First Posted Date

Oct 12, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2012

Last Update Posted Date

Jun 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deepak C. D'Souza, Associate Professor of Psychiatry, Yale UniversityPrincipal Investigator

Lead Sponsor

Yale UniversityOTHER

Collaborators

Name	Class
Stanley Medical Research Institute	OTHER
Donaghue Foundation	UNKNOWN
US Department of Veterans Affairs	FED
VA Office of Research and Development

Description Module

Brief Summary

This study will examine the effectiveness of D-serine in increasing and sustaining the benefits of cognitive retraining in people with schizophrenia.

Detailed Description

This study is based on the hypothesis that by increasing NMDA receptor function in the brain and thereby increasing the capacity of the brain to both form new connections and strengthen existing connections, schizophrenic patients may derive both greater and sustained benefit from cognitive retraining.

Patients with schizophrenia or schizoaffective disorder who are currently receiving antipsychotic medication will be randomly assigned in a double-blind manner to receive either D-serine (30 mg/kg) or placebo in addition to cognitive rehabilitation or a non-interactive placebo for 12 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive and Negative Syndrome Scale (PANSS)
Wisconsin Card Sorting Test (WCST)
Hopkins Verbal Learning Test
Spatial working memory task

Secondary Outcomes

Measure	Description	Time Frame
Heinrichs-Carpenter Quality of Life Scale
Neurocognitive training tasks
Functional assessments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of schizophrenia or schizoaffective disorder
Clinically stable
Treated with antipsychotic medications for at least 6 months in the past, and on a stable dose of the same antipsychotic medication over the past month
Not pregnant or lactating

Exclusion Criteria:

Other current or past DSM-IV Axis I diagnosis
Calgary Depression scale score >10 or Simpson-Angus Rating Scale score > 20
Currently treated with clozapine, lamotrigine or carbamazepine, or defined as treatment refractory
Substance abuse or dependence within the past 3 months, except for nicotine
Wechsler Adult Intelligence Scale-Revised score < 70
Significant recent (within past 3 months) risk of committing suicide
Abnormal thyroid function tests within the last 6 months
Previous treatment with D-serine
History of evidence of a medical or neurological condition that would expose the subject to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the trial
Clinically significant abnormal laboratory test results at screening
ECT treatment within the past two months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepak C. D'Souza, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Mental Health and Neurosciences		Bangalore	Karnataka	560029	India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
10553752	Background	Tsai GE, Yang P, Chung LC, Tsai IC, Tsai CW, Coyle JT. D-serine added to clozapine for the treatment of schizophrenia. Am J Psychiatry. 1999 Nov;156(11):1822-5. doi: 10.1176/ajp.156.11.1822.
9836012	Background	Tsai G, Yang P, Chung LC, Lange N, Coyle JT. D-serine added to antipsychotics for the treatment of schizophrenia. Biol Psychiatry. 1998 Dec 1;44(11):1081-9. doi: 10.1016/s0006-3223(98)00279-0.

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders