Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628394
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : June 22, 2012
National Institute of Mental Health (NIMH)
Stanley Medical Research Institute
Information provided by (Responsible Party):
Carol A. Tamminga, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Cognition in Schizophrenia Drug: Atomoxetine Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Treatments in Schizophrenia
Study Start Date : September 2003
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Patients are given the drug Atomoxetine and Cognitive Remediation training.
Drug: Atomoxetine
40mg 2po qam
Other Name: Strattera
Patients are given the drug Atomoxetine and Remediation Control training.
Drug: Atomoxetine
40mg 2po qam
Other Name: Strattera
Patients are given a Placebo and Cognitive Remediation training.
Drug: Placebo
40mg 2po qam
Other Name: Cornstarch capsule
Patients are given Placebo and Remediation Control training.
Drug: Placebo
40mg 2po qam
Other Name: Cornstarch capsule

Primary Outcome Measures :
  1. Composite neuropsychological measures for MATRICS [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. PANSS change, Birchwood SFS change, and fMRI BOLD change [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628394

United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Mental Health (NIMH)
Stanley Medical Research Institute
Principal Investigator: Carol A Tamminga, MD UT Southwestern Medical Center

Responsible Party: Carol A. Tamminga, Principal Investigator, University of Texas Southwestern Medical Center Identifier: NCT00628394     History of Changes
Other Study ID Numbers: 0803-476
1R34MH075863-01A2 ( U.S. NIH Grant/Contract )
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: June 22, 2012
Last Verified: June 2012

Keywords provided by Carol A. Tamminga, University of Texas Southwestern Medical Center:
cognitive remediation

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs