Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

This study has been completed.
Sponsor:
Collaborators:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Carol A. Tamminga, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00628394
First received: February 24, 2008
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Cognition in Schizophrenia
Drug: Atomoxetine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Treatments in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Composite neuropsychological measures for MATRICS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PANSS change, Birchwood SFS change, and fMRI BOLD change [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: September 2003
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Drug: Atomoxetine
40mg 2po qam
Other Name: Strattera
2
Patients are given the drug Atomoxetine and Remediation Control training.
Drug: Atomoxetine
40mg 2po qam
Other Name: Strattera
3
Patients are given a Placebo and Cognitive Remediation training.
Drug: Placebo
40mg 2po qam
Other Name: Cornstarch capsule
4
Patients are given Placebo and Remediation Control training.
Drug: Placebo
40mg 2po qam
Other Name: Cornstarch capsule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628394

Locations
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Stanley Medical Research Institute
Investigators
Principal Investigator: Carol A Tamminga, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Carol A. Tamminga, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00628394     History of Changes
Other Study ID Numbers: 0803-476, 1 R34 MH075863-01A2
Study First Received: February 24, 2008
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Cognition
schizophrenia
Atomoxetine
Strattera
cognitive remediation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Atomoxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014