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Bipolar II Depression: Lithium, SSRI, or the Combination
This study is currently recruiting participants.
Study NCT00276965   Information provided by National Institute of Mental Health (NIMH)
First Received: January 12, 2006   Last Updated: March 12, 2009   History of Changes

January 12, 2006
March 12, 2009
September 2006
June 2011   (final data collection date for primary outcome measure)
Determine switch rate to Mania/hypomania [ Time Frame: Measured at week 16 ] [ Designated as safety issue: No ]
  • Mania/hypomania [ Time Frame: Measured at Week 16 ]
  • Side effects [ Time Frame: Measured at Week 16 ]
  • Antidepressant response [ Time Frame: Measured at Week 16 ]
  • Mood variability [ Time Frame: Measured at Week 16 ]
Complete list of historical versions of study NCT00276965 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Bipolar II Depression: Lithium, SSRI, or the Combination
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.

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.

Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
  • Bipolar Disorder
  • Depression
  • Drug: Sertraline
  • Drug: Lithium carbonate
  • Experimental: Participants will take lithium only.
  • Experimental: Participants will take lithium and sertraline.
  • Experimental: Participants will take sertraline only.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
70
September 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Susan L. McElroy, MD 513-536-0700 susan.mcelroy@lindnercenter.org
Contact: Brian E Martens, MS 513-536-0720 brian.martens@lindnercenter.org
United States
 
NCT00276965
Mi Hillefors, MD, PhD, Program Officer, Experimental Therapeutics Branch, NIMH
R01 MH074707, DATR A5-ETMA
National Institute of Mental Health (NIMH)
 
Principal Investigator: Lori Altshuler, MD UCLA Mood Disorders Research Program
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP