Treating Cognition in Schizophrenia With Atomoxetine and Cognitive Remediation
Condition: Cognition in Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 40mg 2po qam; 40mg 2po qam
Other intervention name(s): Strattera; Cornstarch capsule
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cognition; schizophrenia; Atomoxetine; Strattera; cognitive remediation