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

Sponsor:	University of Pittsburgh
Collaborator:	Stanley Medical Research Institute
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00222794

Purpose

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.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: Atomoxetine (Strattera)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Parallel Group, Double Blind, Placebo Controlled, Clinical Trial of Augmentation With Atomoxetine for the Treatment of Negative Symptoms in Patients With Schizophrenia and Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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).

Estimated Enrollment:	66
Study Start Date:	November 2003
Study Completion Date:	July 2006

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 with an atypical antipsychotic agent in remitted community dwelling subjects with Schizophrenia or Schizoaffective disorder. Atomoxetine was recently approved by the FDA for the treatment of Attention Deficit Hyperactivity Disorder in children and adults. All subjects will receive various psychometric assessments at 2-week intervals for a period of 26 weeks. It is hypothesized that subjects treated with Atomoxetine in this 26 week random assignment, parallel-group, double-blind, placebo-controlled study, will have a significantly greater improvement in quality of life and social functioning.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222794

Locations

United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213

Sponsors and Collaborators

University of Pittsburgh

Stanley Medical Research Institute

Investigators

Principal Investigator:

Rohan Ganguli, MD

University of Pittsburgh

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00222794 History of Changes
Other Study ID Numbers:	0308023, 03T-327
Study First Received:	September 8, 2005
Last Updated:	August 30, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Schizophrenia
Schizo-Affective Disorder
Negative Symptoms
Atomoxetine
Strattera

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Atomoxetine
Adrenergic Uptake Inhibitors

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012