Maintenance Treatment of Bipolar Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Charles L. Bowden, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00183469
First received: September 13, 2005
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.


Condition Intervention Phase
Bipolar Disorder
Depression
Drug: Lamotrigine (LAM)
Drug: Divalproex (DIV)
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Rates of response to treatment regimen [ Time Frame: Measured at Week 32 ] [ Designated as safety issue: Yes ]

Enrollment: 164
Study Start Date: December 2004
Study Completion Date: April 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Participants will take active lamotrigine and active divalproex
Drug: Lamotrigine (LAM)
If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.
Other Name: Lamictal
Drug: Divalproex (DIV)
If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.
Other Names:
  • Depakote
  • Divalproic Acid
Placebo Comparator: 2
Participants will take active lamotrigine and placebo
Drug: Lamotrigine (LAM)
If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.
Other Name: Lamictal
Drug: Placebo
During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fasion.

Detailed Description:

Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.

Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of bipolar disorder I or II
  • Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
  • Willing to use acceptable methods of contraception
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • History of liver disease
  • History of substance abuse
  • Previous treatment with lamotrigine or divalproex
  • Lamotrigine or divalproex intolerance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183469

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Charles L. Bowden, MD 210-567-5405
  More Information

Publications:
Responsible Party: Charles L. Bowden, Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00183469     History of Changes
Other Study ID Numbers: P20 MH68662, 5P20MH068662, DSIR 83-ATSO
Study First Received: September 13, 2005
Last Updated: December 7, 2012
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center at San Antonio:
Lamotrigine
Divalproex
Antidepressant

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lamotrigine
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 23, 2014