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Bipolar II Depression: Lithium, SSRI, or the Combination

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Stanford University
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00276965
First received: January 12, 2006
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

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 ]

Enrollment: 139
Study Start Date: September 2006
Study Completion Date: July 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Eskalith, Lithobid
Experimental: B
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
Other Name: Zoloft
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 Name: Eskalith, Lithobid
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 Name: Zoloft

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
  • 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

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
Stanford University - Bipolar Research Program
Palo Alto, California, United States, 94304
United States, Ohio
Lindner Center of HOPE, affliated with University of Cincinnati Medical Center
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
National Institute of Mental Health (NIMH)
University of California, Los Angeles
Stanford University
Investigators
Principal Investigator: Lori Altshuler, MD UCLA Mood Disorders Research Program
  More Information

No publications provided

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00276965     History of Changes
Other Study ID Numbers: R01 MH074707, R01MH074707, DATR A5-ETMA
Study First Received: January 12, 2006
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by Lindner Center of HOPE:
Bipolar II Depression

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lithium
Lithium Carbonate
Sertraline
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Serotonin Agents

ClinicalTrials.gov processed this record on May 16, 2013