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Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

Primary Purpose

Cognition in Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognition in Schizophrenia focused on measuring Cognition, schizophrenia, Atomoxetine, Strattera, cognitive remediation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Atomox/CR

Atomox/Control

Placebo/CR

Placebo/Control

Arm Description

Patients are given the drug Atomoxetine and Cognitive Remediation training.

Patients are given the drug Atomoxetine and Remediation Control training.

Patients are given a Placebo and Cognitive Remediation training.

Patients are given Placebo and Remediation Control training.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinical Outcomes
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.

Full Information

First Posted
February 24, 2008
Last Updated
September 24, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH), Stanley Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00628394
Brief Title
Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation
Official Title
Cognitive Treatments in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Mental Health (NIMH), Stanley Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognition in Schizophrenia
Keywords
Cognition, schizophrenia, Atomoxetine, Strattera, cognitive remediation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomox/CR
Arm Type
Other
Arm Description
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Arm Title
Atomox/Control
Arm Type
Other
Arm Description
Patients are given the drug Atomoxetine and Remediation Control training.
Arm Title
Placebo/CR
Arm Type
Other
Arm Description
Patients are given a Placebo and Cognitive Remediation training.
Arm Title
Placebo/Control
Arm Type
Other
Arm Description
Patients are given Placebo and Remediation Control training.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
40mg 2po qam
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Cornstarch capsule
Intervention Description
40mg 2po qam
Primary Outcome Measure Information:
Title
Neuropsychological Measures for MATRICS
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical Outcomes
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol A Tamminga, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

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Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

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