Bipolar II Depression: Lithium, SSRI, or the Combination

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276965
• Other study ID #: R01MH074707
• Secondary ID: R01MH074707DATR
• Status: Completed
• Phase: Phase 3
• First received: January 12, 2006
• Last updated: May 8, 2013
• Start date: September 2006
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Lindner Center of HOPE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Sertraline
Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day
• 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).

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California
United States	Lindner Center of HOPE, affliated with University of Cincinnati Medical Center	Mason	Ohio
United States	Stanford University - Bipolar Research Program	Palo Alto	California

Sponsors (4)

Lead Sponsor	Collaborator
Lindner Center of HOPE	National Institute of Mental Health (NIMH), Stanford University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine switch rate to Mania/hypomania		Measured at week 16	No
Secondary	Side effects		Measured at week 16	No
Secondary	Antidepressant response		Measured at week 16	No
Secondary	Mood variability		Measured at week 16	No