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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Cephalon | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| armodafinil (Nuvigil) | Drug | armodafinil (Nuvigil)150 mg qd |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| William V Bobo, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21641776 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ARM + APD | armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd |
| FG001 | PLC + APD | identical in appearance to active comparator placebo: identical in appearance to active comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ARM + APD | armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd |
| BG001 | PLC + APD | identical in appearance to active comparator placebo: identical in appearance to active comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Error | d prime score | Baseline and week 6 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ARM + APD | armodafinil (Nuvigil) 150 mg armodafinil (Nuvigil): armodafinil (Nuvigil)150 mg qd |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| worsening of psychiatric symptoms | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert Y Meltzer | Northwestern University | 1 312 503 0309 | h-meltzer@northwestern.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| placebo |
| Drug |
identical in appearance to active comparator |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | PLC + APD | identical in appearance to active comparator placebo: identical in appearance to active comparator |
|
|
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| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | PLC + APD | identical in appearance to active comparator placebo: identical in appearance to active comparator | 0 | 29 | 0 | 29 | 0 | 29 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |