Bipolar II Depression: Lithium, SSRI, or the Combination

May 8, 2013 updated by: Lindner Center of HOPE

Comparing the Safety and Effectiveness of a Mood Stabilizing Medication, an Antidepressant Medication, and a Combination of Both Medications to Treat Symptoms of Bipolar Type II Depression

This study will compare the safety and effectiveness of a mood stabilizing medication, an antidepressant medication, and a combination of both medications to treat symptoms of bipolar type II depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Bipolar type II depression (BD II) is a less severe type of bipolar disorder. BD II is characterized by one or more depressive episodes and at least one hypomanic episode. During hypomanic episodes, people experience especially energetic or anxious moods, and their thoughts are more sporadic than usual, but they do not experience the severity of mania. Symptoms of BD II are known to impair daily functioning as well as cause distress and even suicide. Antidepressant medication alone is not recommended for people with bipolar disorder because manic symptoms usually worsen. It is unknown whether the same recommendation should apply to people with BD II. Sertraline is a selective serotonin reuptake inhibitor (SSRI) antidepressant that increases levels of serotonin, helping the brain to maintain mental stability. It is often used to treat depression, panic attacks, and other disorders. Lithium is a mood stabilizing medication that decreases abnormal brain activity and is used to treat and prevent recurring episodes of mania in people with bipolar disorders. This study will evaluate the effectiveness of lithium alone, sertraline alone, and lithium with sertraline to treat symptoms of BD II.

Participation in this double-blind study will last up to 18 weeks. Participants will be randomly assigned to receive either lithium, sertraline, or lithium and sertraline. Both medications will initially be given at a low dose and then gradually increased over 2 weeks. For the remainder of the study, dosages will be adjusted as necessary. Study visits will occur every week for the first 6 weeks and then every other week for the remaining 10 weeks. During all study visits, participants will complete a psychiatric assessment and questionnaires about their current mood and any treatment side effects. Urine and blood collection may occur at selected times during the study.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA
      • Palo Alto, California, United States, 94304
        • Stanford University - Bipolar Research Program
    • Ohio
      • Mason, Ohio, United States, 45040
        • Lindner Center of HOPE, affliated with University of Cincinnati Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets DSM-IV criteria for bipolar type II disorder by Structured Clinical Interview for DSM-IV (SCID)
  • Meets DSM-IV criteria for current depressive episode
  • Inventory of Depressive Symptomology (IDS-C) score greater than 22
  • Clinical Global Impression Scale for Bipolar Illness (CGI-BP) depression subscale score greater than 3 (mildly ill or greater) and mania subscale score of 1 (not ill)
  • Young Mania Rating Scale (YMRS) score less than 8
  • Willing to discontinue antidepressant medication
  • Considered stable and does not require adjustments in treatment for other conditions or illnesses
  • Willing to use an effective form of birth control throughout the study
  • Speaks English

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Unsuccessfully treated for more than 6 weeks with sertraline or lithium for depression
  • Suicidal
  • Significant alcohol or substance abuse or dependence within 3 months of study entry
  • Diagnosed with Axis II borderline personality disorder
  • Psychotic
  • Organic mood disorder (e.g., head trauma or cerebrovascular accident preceding mood episode)
  • Active hepatitis, liver failure, or kidney failure
  • Creatinine greater than 1 mg/dL
  • Liver function tests greater than 3 times the upper limit of normal
  • Abnormal thyroid-stimulating hormone
  • Unstable medical condition

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Participants will take lithium only.
Drug: Lithium carbonate
Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
Other Names:
  • Eskalith, Lithobid
Experimental: B
Participants will take lithium and sertraline.
Drug: Lithium carbonate
Lithium or placebo for lithium starting at 150 mg per day; target dose of 900mg per day. Maximum dose based on clinical response and serum levels (maximum serum level of 1.2 mEq/L).
Other Names:
  • Eskalith, Lithobid
Drug: Sertraline
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
Other Names:
  • Zoloft
Experimental: C
Participants will take sertraline only.
Drug: Sertraline
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
Other Names:
  • Zoloft

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine switch rate to Mania/hypomania
Time Frame: Measured at week 16
Measured at week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: Measured at week 16
Measured at week 16
Antidepressant response
Time Frame: Measured at week 16
Measured at week 16
Mood variability
Time Frame: Measured at week 16
Measured at week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lindner Center of HOPE

Collaborators

National Institute of Mental Health (NIMH)
University of California, Los Angeles
Stanford University

Investigators

  • Principal Investigator: Lori Altshuler, MD, UCLA Mood Disorders Research Program

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 12, 2006

First Submitted That Met QC Criteria

January 12, 2006

First Posted (Estimate)

January 13, 2006

Study Record Updates

Last Update Posted (Estimate)

May 10, 2013

Last Update Submitted That Met QC Criteria

May 8, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH074707 (U.S. NIH Grant/Contract)
  • DATR A5-ETMA (Other Identifier: NIH)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Lithium carbonate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe