NCT00488163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 schizophrenia

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

2.2 years

First QC Date

June 18, 2007

Last Update Submit

October 3, 2017

Conditions

Schizophrenia

Keywords

schizophreniacognitionatomoxetinenorepinephrinedopamine

Outcome Measures

Primary Outcomes (1)

  • Composite score on the Brief Assessment of Cognition in Schizophrenia

    Cognitive performance as measured by the BACS

    8 weeks

Secondary Outcomes (1)

  • Brain activation measured by functional magnetic resonance imaging

    8 weeks

Study Arms (2)

Atomoxetine

ACTIVE COMPARATOR

Atomoxetine 40 mg compounded into capsules.

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Inactive matching compounding of placebo capsules

Drug: Atomoxetine

Interventions

AtomoxetineDRUG

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

Also known as: Strattera®
AtomoxetinePlacebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pilgrim Psychiatric Center

Brentwood, New York, 11717, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Related Publications (1)

  • 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.

    PMID: 12431845BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Joseph I Friedman, MD

    Pilgrim Psychiatric Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 20, 2007

Study Start

January 1, 2005

Primary Completion

April 1, 2007

Study Completion

June 1, 2007

Last Updated

October 5, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)