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Acute Treatment of Bipolar II Depression | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Acute Treatment of Bipolar II Depression

NCT00074776•Stanford University

Summary

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

Detailed 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.

Eligibility

Age

18 - 55 years

Sex

ALL

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

Locations (1)

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Key Dates

Start Date

May 1, 2003

Primary Completion Date

October 1, 2007

Completion Date

October 1, 2007

Last Updated

July 23, 2012

Enrollment

102

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Lithium

DRUG

Lamotrigine

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 23, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Acute Treatment of Bipolar II Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

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