Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, cognition
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.
Interventions
DRUGarmodafinil (Nuvigil)
armodafinil (Nuvigil)150 mg qd
DRUGplacebo
identical in appearance to active comparator
Sponsors
National Alliance for Research on Schizophrenia and Depression
Cephalon
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ARM + APD armodafinil (Nuvigil) 150 mg
armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd | 29 |
| PLC + APD identical in appearance to active comparator
placebo: identical in appearance to active comparator | 29 |
| Total | 58 |
Baseline characteristics
| Characteristic | PLC + APD | ARM + APD | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 29 Participants | 29 Participants | 58 Participants |
| Age, Continuous | 38.8 years STANDARD_DEVIATION 11.7 | 44 years STANDARD_DEVIATION 14.6 | 41.4 years STANDARD_DEVIATION 13.15 |
| Region of Enrollment United States | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Female | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 29 |
| other Total, other adverse events | 1 / 29 | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 | 0 / 29 |
Outcome results
Primary
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.
Time frame: Baseline and week 6
Population: Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARM + APD | Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score | Baseline | 2.7 d prime score | Standard Error 0.3 |
| ARM + APD | Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score | 6 weeks | 2.3 d prime score | Standard Error 0.4 |
| PLC + APD | Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score | Baseline | 2.5 d prime score | Standard Error 0.3 |
| PLC + APD | Cognition Measured by AX-Continuous Performance Test (AX-CPT) D-prime Score | 6 weeks | 3.2 d prime score | Standard Error 0.4 |
Comparison: Treatment effects were analyzed using a repeated measures analysis of variance model with time (baseline, 6 weeks) as the within-subjects factor and treatment group (armodafinil, placebo) as the between-subjects factor.p-value: <0.016t-test, 2 sided