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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00222794
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : August 31, 2010
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: Atomoxetine (Strattera) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2003
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




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

Secondary Outcome Measures :
  1. To examine the effect of atomoxetine therapy on quality of life
  2. To examine safety of adjunctive treatment with atomoxetine
  3. To examine the effects of atomoxetine therapy on other domains of psychopathology (positive symptoms, depressive symptoms, general psychopathology).


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222794


Locations
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United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Stanley Medical Research Institute
Investigators
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Principal Investigator: Rohan Ganguli, MD University of Pittsburgh
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ClinicalTrials.gov Identifier: NCT00222794    
Other Study ID Numbers: 0308023
03T-327
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: January 2008
Keywords provided by University of Pittsburgh:
Schizophrenia
Schizo-Affective Disorder
Negative Symptoms
Atomoxetine
Strattera
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs