Phase 4
N=53
Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation
Cognition in Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00628394 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Neuropsychological Measures for MATRICS — 20.82; 18.03; 25.43; 11.64 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuropsychological Measures for MATRICS |
20.82; 18.03; 25.43; 11.64 | — |
| SECONDARY Clinical Outcomes |
9.75; 10.32; 10.82; 9.02 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00628394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.