Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of Schizophrenia

This study has been completed.

First Received: September 8, 2005 Last Updated: June 6, 2008 History of Changes

Sponsored by:	University of Maryland
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00161031

Purpose

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	Intervention
Schizophrenia	Drug: Atomoxetine

MedlinePlus related topics: Memory Methamphetamine Schizophrenia

Drug Information available for: Atomoxetine hydrochloride Atomoxetine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	Atomoxetine as an Adjunct to Novel Antipsychotic Medication in the Treatment of Cognitive Deficits of Schizophrenia

Further study details as provided by University of Maryland:

Primary Outcome Measures:

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:

Examine whether adjunctive atomoxetine is more effective than placebo for positive symptoms and negative symptom measures.

Estimated Enrollment:	30
Study Start Date:	April 2004
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00161031

Locations

United States, Maryland
Maryland Psychiatric Research Center
Catonsville, Maryland, United States, 21228
Veterans Affairs Maryland Health Care System
Baltimore, Maryland, United States, 21228

Sponsors and Collaborators

University of Maryland

Investigators

Principal Investigator:

Deanna L Kelly, Pharm.D.

MPRC

More Information

No publications provided by University of Maryland

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Kelly DL, Buchanan RW, Boggs DL, McMahon RP, Dickinson D, Nelson M, Gold JM, Ball MP, Feldman S, Liu F, Conley RR. A randomized double-blind trial of atomoxetine for cognitive impairments in 32 people with schizophrenia. J Clin Psychiatry. 2009 Apr;70(4):518-25. Epub 2009 Apr 7.

Study ID Numbers:	H-21702
Study First Received:	September 8, 2005
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00161031 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Schizophrenia
Neurotransmitter Agents
Tranquilizing Agents
Adrenergic Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Atomoxetine
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Atomoxetine

Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Mental Disorders
Therapeutic Uses
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009