NCT00333970

Brief Summary

The purpose of this study is to determine which variables predict improvement on a cognitive training task battery, used for patients with schizophrenia, and to determine the proportion of patients whose performance returns to normal following cognitive training

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

9.2 years

First QC Date

June 2, 2006

Results QC Date

October 2, 2014

Last Update Submit

October 6, 2014

Conditions

Schizophrenia

Keywords

cognitionneuropsychologyRehabilitationtreatment efficacycognitive remediation

Outcome Measures

Primary Outcomes (1)

  • Cognitive Performance

    Change in verbal memory scores from baseline to end of active phase (2 months), measured as trials 1-5 total score on the California Verbal Learning Test -II (range 0-80, higher scores represent better performance).

    baseline and 2 months

Study Arms (2)

cognitive remediation

EXPERIMENTAL

cognitive remediation

Behavioral: cognitive remediation

treatment as usual

NO INTERVENTION

treatment as usual

Interventions

cognitive remediationBEHAVIORAL

individual cognitive training

cognitive remediation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of schizophrenia spectrum disorder
  • English speakers
  • Clinically stable
  • No substance abuse in past 30 days

You may not qualify if:

  • Traumatic brain injury
  • Neurological disease
  • Diagnosis of mental retardation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Joanna Fiszdon
Organization
VA Connecticut Healthcare System
joanna.fiszdon@va.gov
203-932-5711

Study Officials

  • Joanna Fiszdon, PhD

    VA Connecticut Health Care System (West Haven)

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

August 1, 2004

Primary Completion

October 1, 2013

Study Completion

July 1, 2014

Last Updated

October 9, 2014

Results First Posted

October 9, 2014

Record last verified: 2014-10

Locations

US(1)