Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

NCT00628394 | Completed Phase 4 Results

• 2 other identifiers: 0803-4761R34MH075863-01A2
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being done because people with schizophrenia often have problems with thinking including learning, remembering, paying attention, and problem solving. During this study, we will test if cognitive remediation (computer games made to improve thinking), used along with a drug called atomoxetine, may help the problems in thinking as well as some of the symptoms of schizophrenia.

Conditions

Cognition in Schizophrenia

Keywords

Cognition; schizophrenia; Atomoxetine; Strattera; cognitive remediation

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Measures for MATRICS

  Gordon Continuous Performance Test - Distractibility Version The test is designed assess a person's executive functioning by testing their ability to maintain their focus over a period of time. They are intended to respond to a series of targets or inhibit their responses to a variety of foils. They are mainly assessed for their omissions and commissions. The omission and commission errors assess the person's ability to screen out extraneous stimuli while responding correctly and inhibiting incorrect responding. This means lower scores are better. The scale is 0-126.

  12 weeks

Secondary Outcomes (1)

• Clinical Outcomes

  12 weeks

Study Arms (4)

Atomox/CR

OTHER

Patients are given the drug Atomoxetine and Cognitive Remediation training.

Drug: Atomoxetine

Atomox/Control

OTHER

Patients are given the drug Atomoxetine and Remediation Control training.

Drug: Atomoxetine

Placebo/CR

OTHER

Patients are given a Placebo and Cognitive Remediation training.

Drug: Placebo

Placebo/Control

OTHER

Patients are given Placebo and Remediation Control training.

Drug: Placebo

Interventions

Atomoxetine DRUG

40mg 2po qam

Also known as: Strattera

Atomox/CR; Atomox/Control

Placebo DRUG

40mg 2po qam

Also known as: Cornstarch capsule

Placebo/CR; Placebo/Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
• Males and females.
• Ages 18-60 years old.
• All races and ethnicities.

You may not qualify if:

• Diagnosis of an organic brain disease.
• Diagnosis of DSM-IV alcohol or substance abuse within the last month or DSM-IV alcohol or substance dependence within the last 3 months.
• Meet criteria for primary negative symptoms, established by clinical judgment.
• Current or past history of clozapine treatment for antipsychotic non-response.
• Patients hospitalized in a psychiatric hospital within the previous 30 days.
• Patients with an unstable medical condition, as determined by the Investigator
• Colorblindness
• Concurrent treatment with electroconvulsive therapy or psychotherapy.
• Pregnant women.
• Must be able to read, speak, and understand English.
• We do not have the resources necessary to properly study non-English speaking patients in this study. The computer software used for cognitive remediation and some clinical assessments are only available in English. The need to provide such resources in foreign languages would be prohibitive to the successful completion of the study.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Atomoxetine Hydrochloride; Starch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Results Point of Contact

• Title: Carol A. Tamminga, MD
• Organization: University of Texas Southwestern Medical Center

carol.tamminga@utsouthwestern.edu

214-645-2789

Study Officials

• Carol A Tamminga, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2008
• First Posted: March 5, 2008
• Study Start: September 1, 2003
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Locations

US (1)