NCT00276965

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_3

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 10, 2013

Status Verified

May 1, 2013

Enrollment Period

5.5 years

First QC Date

January 12, 2006

Last Update Submit

May 8, 2013

Conditions

Bipolar DisorderDepression

Keywords

Bipolar II Depression

Outcome Measures

Primary Outcomes (1)

  • Determine switch rate to Mania/hypomania

    Measured at week 16

Secondary Outcomes (3)

  • Side effects

    Measured at week 16

  • Antidepressant response

    Measured at week 16

  • Mood variability

    Measured at week 16

Study Arms (3)

A

EXPERIMENTAL

Participants will take lithium only.

Drug: Lithium carbonate

B

EXPERIMENTAL

Participants will take lithium and sertraline.

Drug: SertralineDrug: Lithium carbonate

C

EXPERIMENTAL

Participants will take sertraline only.

Drug: Sertraline

Interventions

SertralineDRUG

Sertraline or placebo for sertraline starting at 25 mg per day, up to maximum of 200 mg per day

Also known as: Zoloft
BC
Lithium carbonateDRUG

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).

Also known as: Eskalith, Lithobid
AB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UCLA

Los Angeles, California, 90095, United States

Location

Stanford University - Bipolar Research Program

Palo Alto, California, 94304, United States

Location

Lindner Center of HOPE, affliated with University of Cincinnati Medical Center

Mason, Ohio, 45040, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

SertralineLithium Carbonate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium Compounds

Study Officials

  • Lori Altshuler, MD

    UCLA Mood Disorders Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2006

First Posted

January 13, 2006

Study Start

September 1, 2006

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

May 10, 2013

Record last verified: 2013-05

Locations

US(3)