Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

September 24, 2020 updated by: Carol A. Tamminga, University of Texas Southwestern Medical Center

Cognitive Treatments in Schizophrenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persons with schizophrenia in a stable and residual antipsychotic- treated clinical condition for at least 8 weeks will be recruited from several public mental health treatment settings into the UTSW Schizophrenia Research Clinic. Each volunteer will receive information about the protocol and its risks and benefits. If they give their informed consent after a full opportunity to learn about the details of the study, they will be allowed to proceed. All recruits will have been treated with optimal dosing of any 2nd generation antipsychotic drug (APD-2) and will have been clinically stable with respect to psychotic symptoms for at least 6 weeks prior to randomization, and on a stable dose of the medication for at least 2 weeks. All eligible volunteers will receive a routine medical assessment and psychiatric diagnostic work-up including the SCID and a consensus diagnosis by two experienced clinicians based on all available data, prior to the randomization. Just prior to randomization, the following sets of assessments will be performed: (1) Medical: Physical Examination, Clinical Chemistries, EKG, urinalysis, weight, and vital signs; (2) Symptomatic: general psychiatric symptom assessment, including the scores on the PANSS, Psychosis Change Scale, and CGI; (3) Cognitive: standard neuropsychometric test battery and surrogate psychosocial tests; all of the assessment batteries will be repeated at the end of the 12-week treatment period, and repeated again at the end of the three month follow-up period (at 6 months from study start). Clinical symptom scales, weight, and vital signs will be repeated at weeks 4, 8, 12, 16 , and 24 during the study.

The schizophrenia volunteers will be randomized into four treatment groups: (1) atomoxetine plus cognitive remediation; (2) atomoxetine plus remediation control; (3) placebo plus cognitive remediation; and (4) placebo plus remediation control. Atomoxetine or matching placebo will be administered at a dose of 40mg bid (80mg/day) or the placebo equivalent. The remediation sequence will last for 60 minutes and will be administered three times weekly; the remediation control will be administered on the same schedule and for the same duration. Because the volunteers attend the clinic so regularly, we will have an opportunity to track their progress, monitor medication adherence, and optimize study participation.

Then, each volunteer will be followed up while taking their blinded study medications, but without any more remediation/control sessions, for the next 3 months. Psychiatric rating scales will be completed the following times, relative to the blinded randomization: baseline, 1, 2, 3, 4, 5, 6 months, whereas the neuropsychological battery will be completed at baseline and at 3 and 6 months.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Atomox/CR
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Drug: Atomoxetine
40mg 2po qam
Other Names:
  • Strattera
Other: Atomox/Control
Patients are given the drug Atomoxetine and Remediation Control training.
Drug: Atomoxetine
40mg 2po qam
Other Names:
  • Strattera
Other: Placebo/CR
Patients are given a Placebo and Cognitive Remediation training.
Drug: Placebo
40mg 2po qam
Other Names:
  • Cornstarch capsule
Other: Placebo/Control
Patients are given Placebo and Remediation Control training.
Drug: Placebo
40mg 2po qam
Other Names:
  • Cornstarch capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychological Measures for MATRICS
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes
Time Frame: 12 weeks
Birchwood Social Function Scale (SFS) This scale is given to determine a person's ability to function independently and in social settings without difficulty. It assesses a variety of settings with independent subscales (whose scores vary in range) but in which the higher score is always better. These subscales (Withdrawal/Social Engagement; Interpersonal Communication; Independence-Performance; Independence-Competence; Recreation; Prosocial; and, Employment/Occupation) are combined and developed into a mean score. These scores range from 0-32.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)
Stanley Medical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 24, 2008

First Submitted That Met QC Criteria

February 24, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Actual)

September 25, 2020

Last Update Submitted That Met QC Criteria

September 24, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0803-476
  • 1R34MH075863-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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