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Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia

NCT ID: NCT00488163

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atomoxetine

Atomoxetine 40 mg compounded into capsules.

Group Type ACTIVE_COMPARATOR

Atomoxetine

Intervention Type DRUG

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

Placebo

Inactive matching compounding of placebo capsules

Group Type PLACEBO_COMPARATOR

Atomoxetine

Intervention Type DRUG

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

Interventions

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Atomoxetine

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

Intervention Type DRUG

Other Intervention Names

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Strattera®

Eligibility Criteria

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Inclusion Criteria

1. Subjects will be males and females between the ages of 18 and 65
2. In good general medical health
3. For patient subjects, a DSM-IV diagnosis of schizophrenia, any subtype
4. Currently in remission or with stable, unchanging residual symptoms
5. Receiving treatment with olanzapine, aripiprazole, risperidone, or quetiapine as their antipsychotic medication at a stable dose for a minimum of eight weeks.
6. Able to complete neurocognitive tests
7. 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

1. Recent history (within previous year) of serious suicide, homicide, or physical violence, or current suicidal or homicidal thoughts
2. Any axis I DSM-IV diagnosis in addition to schizophrenia or schizoaffective disorder except substance abuse in remission
3. History of severe head trauma, neurological disorder, or medical illness which may contribute to the subjects' psychiatric symptoms or cognitive impairment
4. Medical illness which requires taking any medication that has CNS activity which is known to impair cognition.
5. Untreated or unstable hypertension.
6. Coronary artery disease.
7. 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
8. Unable to give informed consent
9. History of developmental disorder or less than an eighth
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Research Foundation for Mental Hygiene, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Joseph Friedman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph I Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Pilgrim Psychiatric Center

Locations

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Pilgrim Psychiatric Center

Brentwood, New York, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Countries

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United States

References

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Bymaster FP, Katner JS, Nelson DL, Hemrick-Luecke SK, Threlkeld PG, Heiligenstein JH, Morin SM, Gehlert DR, Perry KW. Atomoxetine increases extracellular levels of norepinephrine and dopamine in prefrontal cortex of rat: a potential mechanism for efficacy in attention deficit/hyperactivity disorder. Neuropsychopharmacology. 2002 Nov;27(5):699-711. doi: 10.1016/S0893-133X(02)00346-9.

Reference Type BACKGROUND
PMID: 12431845 (View on PubMed)

Other Identifiers

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00131-03-1284

Identifier Type: -

Identifier Source: org_study_id