Overview

A Clinical Trial to Examine Effects of Atomoxetine in the Treatment of Negative Symptoms in Patients With Schizophrenia

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
Stanley Medical Research Institute
Treatments:
Atomoxetine Hydrochloride
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.