Bipolar II Depression: Lithium, SSRI, or the Combination - Full Text View

Purpose

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.

Condition	Intervention	Phase
Bipolar Disorder Depression	Drug: Sertraline Drug: Lithium carbonate	Phase III

MedlinePlus related topics:

Antidepressants Bipolar Disorder Depression

ChemIDplus related topics:

Sertraline hydrochloride Sertraline Lithium carbonate Lithium citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Official Title:	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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Determine switch rate to Mania/hypomania [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Side effects [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]
Antidepressant response [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]
Mood variability [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	September 2006
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 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).
B: Experimental Participants will take lithium and sertraline.	Drug: Sertraline Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day 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).
C: Experimental 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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Experienced more than 4 episodes within 1 year of study entry
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276965

Contacts


Contact: Susan L. McElroy, MD	513-558-1133	susan.mcelroy@uc.edu

Locations


United States, California
	UCLA	Recruiting
	Los Angeles, California, United States
	Contact 310-794-6663
	Principal Investigator: Lori Altshuler, MD

United States, Ohio
	University of Cincinnati Medical Center	Recruiting
	Cincinnati, Ohio, United States, 45267-0559
	Contact: Brian Martens, MS, LSW 513-558-5996
	Principal Investigator: Sue McElroy, MD

United States, Texas
	University of Texas, Southwestern Medical Center	Recruiting
	Dallas, Texas, United States
	Contact 214-648-7494 Trisha.Suppes@UTSouthwestern.edu
	Principal Investigator: Trisha Suppes, MD, PhD

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators


Principal Investigator:	Susan L. McElroy, MD	University of Cincinnati

More Information

Responsible Party:	Experimental Therapeutics Branch, NIMH ( Mi Hillefors, MD, PhD, Program Officer )
Study ID Numbers:	R01 MH074707, DATR A5-ETMA
First Received:	January 12, 2006
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00276965
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Bipolar II Depression

Study placed in the following topic categories:

Affective Disorders, Psychotic

Depression

Mental Disorders

Bipolar Disorder

Mood Disorders

Sertraline

Lithium Carbonate

Psychotic Disorders

Depressive Disorder

Serotonin

Lithium

Behavioral Symptoms

Additional relevant MeSH terms:

Neurotransmitter Agents

Neurotransmitter Uptake Inhibitors

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Enzyme Inhibitors

Antimanic Agents

Antipsychotic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Serotonin Agents

Therapeutic Uses

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on July 18, 2008

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00276965