Trial | NCT00488163  Report issue

Official Title

Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
Relationships between altered prefrontal cortical dopamine, norepinephrine and some cognitive impairments of schizophrenia supports and approach for pharmacological remediation of cognitive symptoms through manipulations of prefrontal cortical dopamine and norepinephrine. Atomoxetine, a selective norepinephrine re-uptake inhibitor, produces a widespread increase in brain norepinephrine and a secondary and selective increase in prefrontal dopamine. Given this, we are evaluating atomoxetine's cognitive effects in a pilot placebo controlled trial in patients with schizophrenia. Moreover, an fMRI investigation was undertaken to assess the neural mechanisms underlying the cognitive effects of atomoxetine.
Participants carrying a diagnosis of schizophrenia and receiving treatment with one of the following antipsychotic medications are eleigible for participation: risperidone, olanzapine, quetiapine, aripirazole. Following consent, participants will be observed for 4 weeks to ensure stability of their symptoms. Following this, there will be baseline assessments of symptom severity, cognitive ability, functional ability and an fMRI scan. Following this, participants will be randomly assigned to receive treatment with 40 mg of atomoxetine or placebo daily during a double-blind parallel designed four week treatment period, following which the dose of atomoxetine will be increased to 40 mg twice day (or matching placebo) for an additional 4 weeks. The cognitive assessment battery and MRI will be repeated following 8 weeks of treatment.
Study Started
Jan 31
2005
Primary Completion
Apr 30
2007
Study Completion
Jun 30
2007
Last Update
Oct 05
2017

Drug Atomoxetine

Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.

  • Other names: Strattera®

Atomoxetine Active Comparator

Atomoxetine 40 mg compounded into capsules.

Placebo Placebo Comparator

Inactive matching compounding of placebo capsules

Criteria 

Inclusion Criteria:

Subjects will be males and females between the ages of 18 and 65
In good general medical health
For patient subjects, a DSM-IV diagnosis of schizophrenia, any subtype
Currently in remission or with stable, unchanging residual symptoms
Receiving treatment with olanzapine, aripiprazole, risperidone, or quetiapine as their antipsychotic medication at a stable dose for a minimum of eight weeks.
Able to complete neurocognitive tests
Able to give informed consent. All subjects will be required to have at least an 8th grade reading level and/or a full-scale IQ of at least 85 as assessed by the Wide Range Achievement Test (WRAT).

Exclusion Criteria:

Recent history (within previous year) of serious suicide, homicide, or physical violence, or current suicidal or homicidal thoughts
Any axis I DSM-IV diagnosis in addition to schizophrenia or schizoaffective disorder except substance abuse in remission
History of severe head trauma, neurological disorder, or medical illness which may contribute to the subjects' psychiatric symptoms or cognitive impairment
Medical illness which requires taking any medication that has CNS activity which is known to impair cognition.
Untreated or unstable hypertension.
Coronary artery disease.
Receiving concomitant anticholinergic drugs, antidepressants or mood stabilizers. If patient subjects are receiving benzodiazepines, they must be short or intermediate acting (e.g. alprazolam, lorazepam) and must be held 48 hours prior to cognitive testing
Unable to give informed consent
History of developmental disorder or less than an eighth
No Results Posted