Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

This study is currently recruiting participants.

Verified by Vanderbilt University, September 2009

First Received: September 6, 2006 Last Updated: September 23, 2009 History of Changes

Sponsor:	Vanderbilt University
Collaborators:	National Alliance for Research on Schizophrenia and Depression Cephalon
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00373672

Purpose

This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.

Condition	Intervention	Phase
Schizophrenia Schizoaffective Disorder	Drug: armodafinil (Nuvigil) Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Modafinil Armodafinil

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

cognition [ Time Frame: six weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	August 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator armodafinil (Nuvigil) 150 mg	Drug: armodafinil (Nuvigil) armodafinil (Nuvigil)150 mg qd
2: Placebo Comparator identical in appearance to active comparator	Drug: placebo identical in appearance to active comparator

Eligibility

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

Criteria

Inclusion criteria

Men and women age 18-65 years
Patients with DSM-IV defined schizophrenia or schizoaffective disorder
Treated with any atypical antipsychotic for at least 2 months
Patients with documented weight gain > 7% with current antipsychotic medication
Able to provide written consent

Exclusion criteria

Women who are pregnant or nursing. Female participants must have a negative urine pregnancy test at screening.
DSM-IV defined substance or alcohol dependence within the 2 months preceding the start of the trial
Treatment with a monoamine oxidase inhibitor (e.g., tranylcypromine, phenelzine, isocarboxazid) within 2 weeks of starting the trial
Patients considered at high risk for suicide or violence
Patients with history of or symptoms on systems review consistent with clinically significant and currently relevant hematologic, renal, hepatic, gastrointestinal, endocrine, pulmonary, dermatologic, oncologic or neurologic (including seizures or epilepsy) disease
Patients with a history of or symptoms on systems review consistent with significant cardiovascular disease, bypass surgery, or concurrent cardiovascular disease, including uncontrolled hypertension, hypotension, congestive heart failure, angina pectoris, or recent (within last 6 months) myocardial infarction
Use of any investigational drug within 4 weeks before screening
History of hypersensitivity or other intolerable adverse effects to modafinil
Patients who experience severe sleep disturbances from modafinil

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373672

Contacts

Contact: Kara L Watts, M.A.	615-343-9717	kara.l.watts@vanderbilt.edu
Contact: William V Bobo, M.D.	615-327-7049	william.bobo@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37212
Contact: Kara L Watts, M.A. 615-343-9717 kara.l.watt@vanderbilt.edu
Contact: William V Bobo, M.D. 615-327-7049 william.bobo@vanderbilt.edu
Principal Investigator: William V Bobo, M.D.

Sponsors and Collaborators

Vanderbilt University

National Alliance for Research on Schizophrenia and Depression

Cephalon

Investigators

Principal Investigator:

William V Bobo, M.D.

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University Medical Center ( Herbert Meltzer, M.D. )
Study ID Numbers:	060567
Study First Received:	September 6, 2006
Last Updated:	September 23, 2009
ClinicalTrials.gov Identifier:	NCT00373672 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

schizophrenia
cognition

Additional relevant MeSH terms:

Disease
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Modafinil
Pharmacologic Actions

Schizophrenia
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009