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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
armodafinil (Nuvigil)
placebo
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

armodafinil (Nuvigil) 150 mg

identical in appearance to active comparator

Outcomes

Primary Outcome Measures

cognition

Secondary Outcome Measures

Full Information

First Posted
September 6, 2006
Last Updated
February 22, 2010
Sponsor
Vanderbilt University
Collaborators
National Alliance for Research on Schizophrenia and Depression, Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00373672
Brief Title
Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vanderbilt University
Collaborators
National Alliance for Research on Schizophrenia and Depression, Cephalon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
schizophrenia, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
armodafinil (Nuvigil) 150 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
identical in appearance to active comparator
Intervention Type
Drug
Intervention Name(s)
armodafinil (Nuvigil)
Intervention Description
armodafinil (Nuvigil)150 mg qd
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
identical in appearance to active comparator
Primary Outcome Measure Information:
Title
cognition
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William V Bobo, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21641776
Citation
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.
Results Reference
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Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder

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