A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

Otsuka

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: Lamotrigine + Aripiprazole; Drug: Lamotrigine + Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00277212

CN138-392 ST

Details and patient eligibility

About

Efficacy of Aripiprazole in Combination with Lamotrigine in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients with Recent Manic or Mixed Episode

Enrollment: 1,169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women ≥ 18 years of age meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria for bipolar I disorder, recently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes of sufficient severity to require treatment with a mood stabilizer or antipsychotic

Exclusion criteria

• First manic episode
• Current manic or mixed episode with > 2 years duration
• Treated with aripiprazole within the past 3 months
• Allergic, intolerant, hypersensitive or refractory to aripiprazole or lamotrigine

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,169 participants in 2 patient groups, including a placebo group

A1

Experimental group

Description:

Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole ; Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole

Treatment:

Drug: Lamotrigine + Aripiprazole

A2

Placebo Comparator group

Description:

Phase 2 Double-Blind Treatment: Lamotrigine + Placebo

Treatment:

Drug: Lamotrigine + Placebo