The primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar I disorder.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

The patient has completed 8 weeks of treatment in a Cephalon-sponsored Phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar I disorder.
The patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression.
During the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
The mood stabilizers 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.
The patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s).
The patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator.
The patient has a Young Mania Rating Scale (YMRS) total score of 14 or less at the enrollment visit. Patients who have a YMRS score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment.

Criterios de exclusión

The patient has any Axis I or Axis II disorder apart from bipolar I disorder that became the primary focus of treatment during the double-blind study.
The patient has psychotic symptoms or had psychosis during the double-blind study.
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 met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study.
The patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

Ubicaciones

Teva Investigational Site 237

Buenos Aires, Argentina

Teva Investigational Site 450

Buenos Aires, Argentina

Teva Investigational Site 881

Buenos Aires, Argentina

Teva Investigational Site 884

Buenos Aires, Argentina

Teva Investigational Site 136

Buenos Aires, Argentina

Teva Investigational Site 134

Buenos Aires, Argentina

Teva Investigational Site 235

Buenos Aires, Argentina

Teva Investigational Site 462

Buenos Aires, Argentina

Teva Investigational Site 135

Córdoba, Argentina

Teva Investigational Site 236

Córdoba, Argentina

Teva Investigational Site 371

La Plata, Argentina

Teva Investigational Site 138

La Plata, Buenos Aires, Argentina

Teva Investigational Site 238

Rosario, Argentina

A 6-Month, Open-Label, Flexible-Dosage (150 to 200 mg/Day) Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Armodafinil

Ubicaciones

Teva Investigational Site 237

Teva Investigational Site 450

Teva Investigational Site 881

Teva Investigational Site 884

Teva Investigational Site 136

Teva Investigational Site 134

Teva Investigational Site 235

Teva Investigational Site 462

Teva Investigational Site 135

Teva Investigational Site 236

Teva Investigational Site 371

Teva Investigational Site 138

Teva Investigational Site 238

Patrocinadores