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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00373672
• Other study ID #: 060567
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2006
• Last updated: February 22, 2010
• Start date: August 2006
• Est. completion date: January 2010

Study information

• Verified date: February 2010
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Drug:
• armodafinil (Nuvigil)
armodafinil (Nuvigil)150 mg qd
• placebo
identical in appearance to active comparator

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Cephalon, National Alliance for Research on Schizophrenia and Depression

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognition		six weeks