Treatment Response to Rehabilitation in Patients With Schizophrenia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 25, 2003

Last Updated Date

May 4, 2009

Start Date ^†

December 2001

Current Primary Outcome Measures ^†

Neuropsychological test battery, including measures of visual, verbal memory, and problem-solving abilities [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]
Schizophrenia symptoms [ Time Frame: Measured pre- and post-treament ] [ Designated as safety issue: No ]
UCSD Performance-Based Skills Assessment [ Time Frame: Measured pre- and post-treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00063336 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Treatment Response to Rehabilitation in Patients With Schizophrenia

Official Title ^†

Treatment Response to Rehabilitation in Schizophrenia

Brief Summary

This study will examine the ways in which schizophrenia-related symptoms affect response to a rehabilitation program for people with schizophrenia.

Detailed Description

Patients with schizophrenia often suffer neurocognitive impairment and psychosocial and vocational difficulties. This study will help identify those patients most likely to benefit from existing behavioral treatments and provide clues for how to modify treatments for those who do not benefit.

Two studies will be conducted. The first will investigate the relationship of symptoms and neurocognitive variables at study entry to psychosocial and vocational status 2 years later. The second study will investigate the relationship of symptoms and neurocognitive variables at study entry to treatment response in patients assigned to either a cognitive remediation track or a computer skills track as part of their rehabilitation treatment.

Both the cognitive remediation and computer skills training programs will last 4 to 6 months. Participants will be assessed pre- and post-treatment.

Neuropsychological, psychosocial and vocational status will be measured.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Parallel Assignment, Efficacy Study

Condition ^†

Schizophrenia

Intervention ^†

Behavioral: Cognitive Remediation
Behavioral: Computer-skills training

Study Arms / Comparison Groups

Experimental: Participants will receive cognitive remediation treatment.
Experimental: Participants will receive computer-skills training.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

November 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

DSM-IV criteria for schizophrenia or schizoaffective disorder
In need of intensive outpatient care
Treatment with atypical antipsychotic medication for a minimum of 6 months prior to study entry

Exclusion Criteria:

Auditory or visual impairment
Mental retardation (IQ less than 70)
Traumatic brain injury with loss of consciousness
Presence or history of any neurological illness that may affect brain physiology
Lack of proficiency in English
Concurrent substance abuse and/or dependence

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00063336

Responsible Party

Matthew M. Kurtz, PhD, Schizophrenia Rehabilitation Program, Institutes of Living

Secondary IDs ^††

DSIR AT-SP

Study Sponsor ^†

National Institute of Mental Health (NIMH)

Collaborators ^††

Investigators ^†

Principal Investigator:

Matthew M. Kurtz, PhD

Schizophrenia Rehabilitation Program, Institutes of Living

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.