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Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Sponsored by
Research Foundation for Mental Hygiene, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognition, atomoxetine, norepinephrine, dopamine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pilgrim Psychiatric Center
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atomoxetine

Placebo

Arm Description

Atomoxetine 40 mg compounded into capsules.

Inactive matching compounding of placebo capsules

Outcomes

Primary Outcome Measures

Composite score on the Brief Assessment of Cognition in Schizophrenia
Cognitive performance as measured by the BACS

Secondary Outcome Measures

Brain activation measured by functional magnetic resonance imaging
Differences between changes in brain oxygenation level dependent imaging measures between placebo and Atomoxetine

Full Information

First Posted
June 18, 2007
Last Updated
October 3, 2017
Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00488163
Brief Title
Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia
Official Title
Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Foundation for Mental Hygiene, Inc.
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, cognition, atomoxetine, norepinephrine, dopamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Active Comparator
Arm Description
Atomoxetine 40 mg compounded into capsules.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive matching compounding of placebo capsules
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera®
Intervention Description
Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
Primary Outcome Measure Information:
Title
Composite score on the Brief Assessment of Cognition in Schizophrenia
Description
Cognitive performance as measured by the BACS
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Brain activation measured by functional magnetic resonance imaging
Description
Differences between changes in brain oxygenation level dependent imaging measures between placebo and Atomoxetine
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph I Friedman, MD
Organizational Affiliation
Pilgrim Psychiatric Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pilgrim Psychiatric Center
City
Brentwood
State/Province
New York
ZIP/Postal Code
11717
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12431845
Citation
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.
Results Reference
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Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia

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