The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
Documentation that the patient has had at least 1 previous manic or mixed episode.
The patient has had no more than 6 mood episodes in the last year.
The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Criterios de exclusión

The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period.
The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.

Ubicaciones

Teva Investigational Site 134

Buenos Aires, Argentina

Teva Investigational Site 136

Buenos Aires, Argentina

Teva Investigational Site 881

Buenos Aires, Argentina

Teva Investigational Site 884

Buenos Aires, Argentina

Teva Investigational Site 888

Buenos Aires, Argentina

Teva Investigational Site 236

Córdoba, Argentina

Teva Investigational Site 135

Córdoba Capital, Argentina

Teva Investigational Site 371

La Plata, Argentina

Teva Investigational Site 886

La Plata, Argentina

Teva Investigational Site 138

La Plata, Buenos Aires, Argentina

Teva Investigational Site 882

Mendoza, Argentina

Teva Investigational Site 883

Mendoza, Argentina

Teva Investigational Site 885

Mendoza, Argentina

Teva Investigational Site 887

Mendoza, Argentina

Teva Investigational Site 238

Rosario, Argentina

A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Armodafinil

Placebo

Ubicaciones

Teva Investigational Site 134

Teva Investigational Site 136

Teva Investigational Site 881

Teva Investigational Site 884

Teva Investigational Site 888

Teva Investigational Site 236

Teva Investigational Site 135

Teva Investigational Site 371

Teva Investigational Site 886

Teva Investigational Site 138

Teva Investigational Site 882

Teva Investigational Site 883

Teva Investigational Site 885

Teva Investigational Site 887

Teva Investigational Site 238

Patrocinadores