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

Phase 4

Completed

• Conditions: Schizophrenia; Schizoaffective Disorder
• Interventions: Drug: armodafinil (Nuvigil); Drug: placebo

• Registration Number: NCT00373672
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-01
• Study First Submitted: 2006-09-06
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-08
• Primary Completion: 2010-01
• Study Completion: 2010-01-01
• Results First Submitted: 2017-05-24
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-05
• Last Update Posted: 2025-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armodafinil (Nuvigil)	armodafinil (Nuvigil)	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.
Placebo	placebo	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.

Primary Outcome Measures

Name	Time	Method
Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score	Baseline and week 6	For the AX-CPT, subjects are required to maintain an attentional set across a delay interval in order to overcome a prepotent response tendency (target responses are required when an X is presented but only in the context of a preceding A; non-target conditions are AY, BX and BY). The dependent measure was d-prime at the long delay (calculated as AX hits minus BX false alarms, which is particularly sensitive to context processing impairments in individuals with schizophrenia.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States