NCT00069433

Brief Summary

This study will determine the effectiveness of skills training in people with schizophrenia and the applicability of the acquired skills in the "real world."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2003

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 9, 2003

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

September 24, 2013

Status Verified

September 1, 2013

Enrollment Period

4.6 years

First QC Date

September 24, 2003

Last Update Submit

September 23, 2013

Conditions

Schizophrenia

Keywords

Psychotic Disorders

Interventions

Social skills and symptom management trainingPROCEDURE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder for \> 5 years
  • Use of stable dose risperidone, olanzapine, or quetiapine for at least 1 month with no planned medication changes
  • Social Behavior Scale (SBS) score \> 45
  • Willing and able to provide informed consent

You may not qualify if:

  • Intelligence Quotient \< 70
  • Use of more than one antipsychotic medication
  • Use of benzodiazepines, tricyclic antidepressants, or anticholinergic medication commonly used to treat extrapyramidal symptoms
  • Diagnostic and Statistical Manual (DSM)-IV criteria for alcohol or other substance dependence
  • History of any traumatic brain injury leading to loss of consciousness for \> 30 minutes
  • Diagnosis of a comorbid medical condition that could interfere with antipsychotic medication treatment or the ability to complete the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hall-Brooke-The Center

Bridgeport, Connecticut, 06606, United States

Location

Hall-Brooke Behavioral Health Services

Westport, Connecticut, 06880, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2003

First Posted

October 9, 2003

Study Start

April 1, 2001

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

September 24, 2013

Record last verified: 2013-09

Locations

US(2)