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

NCT00373672 | Completed Phase 4 Results

• 1 other identifier: 060567
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

schizophrenia; cognition

Outcome Measures

Primary Outcomes (1)

• Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score

  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.

  Baseline and week 6

Study Arms (2)

Armodafinil (Nuvigil)

ACTIVE COMPARATOR

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.

Drug: armodafinil (Nuvigil)

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

armodafinil (Nuvigil) DRUG

armodafinil (Nuvigil)150 mg qd

Armodafinil (Nuvigil)

placebo DRUG

identical in appearance to active comparator

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator
• Cephalon: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• 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. doi: 10.1016/j.schres.2011.05.015. Epub 2011 Jun 8.

  PMID: 21641776 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Herbert Y Meltzer
• Organization: Northwestern University

h-meltzer@northwestern.edu

1 312 503 0309

Study Officials

• William V Bobo, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2006
• First Posted: September 8, 2006
• Study Start: August 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Locations

US (1)