Clinical trial NCT00373672: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: schizophrenia
cognition
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Alliance for Research on Schizophrenia and Depression
name: Cephalon
First posted: 2006-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: cognition
timeFrame: six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: William V Bobo, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.