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

This study has been completed.

Sponsor:

Collaborators:

National Alliance for Research on Schizophrenia and Depression

Cephalon

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00373672

First received: September 6, 2006

Last updated: February 22, 2010

Last verified: February 2010

History of Changes

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 armodafinil (Nuvigil) 150 mg	Drug: armodafinil (Nuvigil) armodafinil (Nuvigil)150 mg qd
Placebo Comparator: 2 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

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212

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 by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bobo WV, Woodward ND, Sim MY, Jayathilake K, Meltzer HY. The effect of adjunctive armodafinil on cognitive performance and psychopathology in antipsychotic-treated patients with schizophrenia/schizoaffective disorder: a randomized, double-blind, placebo-controlled trial. Schizophr Res. 2011 Aug;130(1-3):106-13. Epub 2011 Jun 8.

Responsible Party:	Herbert Meltzer, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00373672 History of Changes
Other Study ID Numbers:	060567
Study First Received:	September 6, 2006
Last Updated:	February 22, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

schizophrenia
cognition

Additional relevant MeSH terms:

Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Modafinil
Tranquilizing Agents
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 19, 2013

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