Acute Treatment of Bipolar II Depression

Stanford University

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Lithium; Drug: Lamotrigine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00074776

DSIR 83-ATSO

R21MH067055 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.

Full description

Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.

Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.

Enrollment: 102 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Current diagnosis of bipolar II disorder

Exclusion criteria

• Use of lithium or lamotrigine
• Intolerance to lithium or lamotrigine
• Substance abuse or dependence within the last month
• Suicidal thoughts
• Unstable medical conditions
• Pregnancy or breast-feeding
• Stable on current medications
• Use of fluoxetine (Prozac) within 2 weeks of study
• Require an antipsychotic medication
• Do not speak or read English

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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102 participants in 2 patient groups

1 Lithium

Experimental group

Treatment:

Drug: Lithium

2 Lamotrigine

Experimental group

Treatment:

Drug: Lamotrigine