Status:
COMPLETED
A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Detailed Description
This study proposes to examine the effect of Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor on Negative Symptoms and Quality of Life and its safety when used in conjunction wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2006
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00222794
Start Date
November 1 2003
End Date
July 1 2006
Last Update
August 31 2010
Active Locations (1)
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1
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213