Completed

Acute Treatment of Bipolar II Depression

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Lithium

+ Lamotrigine

Drug
Who is being recruted

Bipolar and Related Disorders+3

+ Mental Disorders

+ Behavioral Symptoms

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: May 2003
See protocol details

Summary

Principal SponsorStanford University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleAcute Treatment of Bipolar II Depression 
NCT00074776
Principal SponsorStanford University
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

102 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bipolar and Related DisordersMental DisordersBehavioral SymptomsBipolar DisorderDepressionMood Disorders

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Texas Southwestern Medical Center at Dallas

Dallas, United StatesSee the location
CompletedOne Study Center