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

Cephalon

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Drug: Placebo; Drug: Armodafinil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01305408

C10953/3073

2010-023623-26 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 399 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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:

  1. 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.
  2. 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.
  3. The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
  4. The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
  5. 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.
  6. The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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399 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.

Treatment:

Drug: Placebo

Armodafinil 150 mg/day

Experimental group

Description:

Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.

Treatment:

Drug: Armodafinil