| September 6, 2006 |
| September 23, 2009 |
| August 2006 |
| July 2009 (final data collection date for primary outcome measure) |
| cognition [ Time Frame: six weeks ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00373672 on ClinicalTrials.gov Archive Site |
| |
| |
| |
| Effects of Armodafinil on Cognition for Patients With Schizophrenia or Schizoaffective Disorder |
| Effect of Addition of Modafinil on the Tolerability and Efficacy for Cognition of Atypical Antipsychotic Drugs in Patients With Schizophrenia or Schizoaffective Disorder |
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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
- Schizophrenia
- Schizoaffective Disorder
|
- Drug: armodafinil (Nuvigil)
- Drug: placebo
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- Active Comparator: armodafinil (Nuvigil) 150 mg
- Placebo Comparator: identical in appearance to active comparator
|
| |
| |
| Recruiting |
| 60 |
| November 2009 |
| July 2009 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years to 65 Years |
| No |
|
|
| United States |
| |
| NCT00373672 |
| Herbert Meltzer, M.D., Vanderbilt University Medical Center |
| 060567 |
| Vanderbilt University |
- National Alliance for Research on Schizophrenia and Depression
- Cephalon
|
| Principal Investigator: |
William V Bobo, M.D. |
Vanderbilt University |
|
|
| Vanderbilt University |
| September 2009 |
