NCT00420498

Brief Summary

The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia will be examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_2 schizophrenia

Timeline
Completed

Started Aug 2005

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 12, 2007

Status Verified

December 1, 2007

First QC Date

January 9, 2007

Last Update Submit

December 11, 2007

Conditions

SchizophreniaCognitionSmoking

Keywords

SchizophreniaPrefrontal Cortical FunctionSmokingCognitionPositive and Negative SymptomsTobaccoCigarette SmokingDopamine

Outcome Measures

Primary Outcomes (1)

  • To examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia.

Secondary Outcomes (1)

  • To examine the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia.

Interventions

Atomoxetine (Strattera™)DRUG

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Between ages 18 and 59;
  • SCID-I for DSM-IV diagnosis of schizophrenia or schizoaffective disorder, and nicotine dependence
  • Smoking at least 15 cigarettes per day, and have expired breath CO level \>10 ppm,
  • Be in stable remission from active psychiatric symptomatology, (as judged by trained clinical staff in the PRISM research program) and be on a stable dose of psychiatric medication(s) for the past 3 months
  • No current abuse or dependence of alcohol or other substances of abuse within the past 3 months,
  • Full scale IQ \> 80,
  • Presence of definable cognitive deficits of interest including VSWM, CPT, and WCST (e.g. at least one standard deviation below average).
  • Able to give informed consent for participation.

You may not qualify if:

  • Meet DSM-IV criteria for other major Axis I disorders besides those specified for each diagnostic group.
  • Current abuse or dependence of alcohol or substances within the last 3 months, and subjects who are methadone maintained will be excluded.
  • Full scale IQ \< 80.
  • Unable to give informed consent.
  • Patients who are pregnant or planning on becoming pregnant will not be included in this study.
  • Patients on paroxetine, fluoxetine, and quinidine will be excluded from this study.
  • Are deemed medically unsafe to take atomoxetine, as judged by the study physician. Contraindications to the use of atomoxetine include hypersensitivity to atomoxetine, concurrent use of monoamine oxidase inhibitors (atomoxetine should be avoided during therapy with or within 2 weeks of discontinuing an MAO inhibitor), and patients with narrow angle glaucoma. Precautions would include concomitant administration with CYP 2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) (which would necessitate a dose adjustment with atomoxetine), liver disease (enhanced risk of toxicity; empiric dose reduction is suggested based on clinical response; the drug should be avoided in acute hepatic failure), patients with hypertension, tachycardia, or other cardiovascular or cerebrovascular disease, patients with or at risk of hypotension , patients with urinary retention or bladder dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center, SAC-115

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

SchizophreniaSmokingCigarette Smoking

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehaviorTobacco SmokingTobacco Use

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Kristi A Sacco, Psy.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2007

First Posted

January 11, 2007

Study Start

August 1, 2005

Study Completion

September 1, 2007

Last Updated

December 12, 2007

Record last verified: 2007-12

Locations

US(1)