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

Northwestern University

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Drug: armodafinil (Nuvigil); Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00373672

060567

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Men and women age 18-65 years
• Patients with Diagnostic and Statistical Manual (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

Armodafinil (Nuvigil)

Active Comparator group

Description:

First group will be randomized to take Armodafinil (Nuvigil) 150 mg, along with their current anti psychotic medication 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.

Treatment:

Drug: armodafinil (Nuvigil)

Placebo

Placebo Comparator group

Description:

Second group will be randomized to take placebo,identical in appearance to active comparator, along with their current anti psychotic medication 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.

Treatment:

Drug: placebo