NCT00161031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

August 19, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

September 8, 2005

Last Update Submit

August 15, 2019

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

AtomoxetineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Veterans Affairs Maryland Health Care System

Baltimore, Maryland, 21228, United States

Location

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

Related Publications (1)

  • 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. doi: 10.4088/jcp.08m04358. Epub 2009 Apr 7.

    PMID: 19358788DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Deanna L Kelly, Pharm.D.

    MPRC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 19, 2019

Record last verified: 2019-08

Locations

US(2)