Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of 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: NCT00161031
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
MPRC, University of Maryland, Baltimore County

Brief Summary:

The purpose of this study is to:

  • To examine wether adjunctive atomoxetine is more effective thank placebo for neuropsychological measures of reaction time, motor speed, psychomotor speed, sustained attention, learning and memory, working memory, and executive functioning. To determine the effect size of atomoxetine on these neuropsychological measures for follow-up studies.
  • To determine if atomoxetine has short-term benefits for improving weight gain and other metabolic abnormalities associated with antipsychotics.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Atomoxetine Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of Schizophrenia
Study Start Date : April 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. Is adjunctive atomoxetine is more effective than placebo for neuropsychological measures of reaction time, motor speed, psychomotor speed, sustained attention, learning and memory, working memory, and executive function.

Secondary Outcome Measures :
  1. Examine whether adjunctive atomoxetine is more effective than placebo for positive symptoms and negative symptom measures.


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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of either schizophrenia or schizoaffective disorder.
  • Caucasian or Non-Caucasian.
  • Subjects will be currently treated with one of the new generation antipsychotics: olanzapine, risperidone, quetiapine, or ziprasidone.
  • Subjects will meet a prior criteria for cognitive impairment severity. The RBANS will be used to determine the level of cognitive impairment.

Exclusion Criteria:

  • History of an organic brain disease.
  • History of DSM-IV alcohol or substance abuse (within the last month), or DSM-IV alcohol or substance dependence (within the last six months).
  • Pregnant women.
  • Uncontrolled hypertension defined as high blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment.
  • Subjects receiving venlafaxine.

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): NCT00161031


Locations
Layout table for location information
United States, Maryland
Veterans Affairs Maryland Health Care System
Baltimore, Maryland, United States, 21228
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Sponsors and Collaborators
University of Maryland
Investigators
Layout table for investigator information
Principal Investigator: Deanna L Kelly, Pharm.D. MPRC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: MPRC, PI, University of Maryland, Baltimore County
ClinicalTrials.gov Identifier: NCT00161031     History of Changes
Other Study ID Numbers: H-21702
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Schizophrenia
Cognition Disorders
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurocognitive Disorders
Antipsychotic Agents
Atomoxetine Hydrochloride
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents