NCT00222794

Brief Summary

This study proposes to examine the effect of atomoxetine on quality of life and negative symptoms such as social withdrawal, lack of interest in things, lack of thought content, flat emotions, slowed body movements and lack of drive and motivation in patients with schizophrenia or schizoaffective disorder. This study also examines the safety of using atomoxetine along with the conventional antipsychotic in these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2003

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

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

August 31, 2010

Status Verified

January 1, 2008

First QC Date

September 8, 2005

Last Update Submit

August 30, 2010

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizo-Affective DisorderNegative SymptomsAtomoxetineStrattera

Outcome Measures

Primary Outcomes (1)

  • To examine efficacy of atomoxetine as an adjunct agent in treatment of negative symptoms in subjects with schizophrenia or schizoaffective disorder.

Secondary Outcomes (3)

  • To examine the effect of atomoxetine therapy on quality of life

  • To examine safety of adjunctive treatment with atomoxetine

  • To examine the effects of atomoxetine therapy on other domains of psychopathology (positive symptoms, depressive symptoms, general psychopathology).

Interventions

Atomoxetine (Strattera)DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female.
  • Ages 18-65 years inclusive.
  • No psychiatric hospitalization in the past 30 days.
  • Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of schizophrenia.
  • Total Positive and Negative Syndrome Scale (PANSS) score of 80 or less on entry.
  • Currently receiving a stable dose of antipsychotic(s) for at least 30 days prior to randomization.
  • Receiving a stable dose of psychotropic medication for at least 30 days
  • Female patients of childbearing age must be using an acceptable method of birth control.
  • A minimum score of 10 on five global ratings of the Scale for the Assessment of Negative Symptoms (SANS) with minimum score of at least 3 on two of the global items and a mean score of 4 or less for General Life Satisfaction on the Lehman's quality of life (QOL) interview.

You may not qualify if:

  • Inability to give informed consent.
  • Current alcohol or substance abuse or dependence within the last 6 months.
  • History of narrow angle glaucoma or organic brain disease.
  • Female patient of childbearing potential without adequate contraception.
  • Uncontrolled diabetes mellitus (a fasting blood glucose of \>126mg/dL), uncontrolled hypertension (a systolic of \>160mm/hg and a diastolic of \>100mm/hg) or orthostatic hypotension, assessed on a case by case basis, liver disease (AST of \> 40 u/L, and ALT of \> 56 u/L), cerebrovascular disorder or myocardial infarction diagnosed 3 months prior to study entry.
  • Concurrently receiving treatment with venlafaxine (Effexor), a MAO inhibitor such as Nardil (phenelzine), or Parnate (tranylcypromine), cytochrome p450 2d6 inhibitors such as fluoxetine (Prozac, Sarafem), paroxetine (Paxil), or quinidine (Cardioquin, Quinidex Extentabs), albuterol (Ventolin, Proventil, Combivent, AccuNeb, Serevent) and all psychostimulants (dextroamphetamine and methylphenidate) currently or within the last 2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Rohan Ganguli, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 22, 2005

Study Start

November 1, 2003

Study Completion

July 1, 2006

Last Updated

August 31, 2010

Record last verified: 2008-01

Locations

US(1)