Maintenance Treatment of Bipolar Depression

NCT00183469 | Completed Phase 4 Results DMC

• 3 other identifiers: P20MH0686625P20MH068662DSIR 83-ATSO
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bipolar Disorder; Depression

Keywords

Lamotrigine; Divalproex; Antidepressant

Outcome Measures

Primary Outcomes (1)

• Mania Rating Scale

  Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.

  up to 8 months

Study Arms (2)

lamotrigine plus divalproex ER

ACTIVE COMPARATOR

Participants will take active lamotrigine and active divalproex ER

Drug: Lamotrigine; Drug: Divalproex (DIV) ER

lamotrigine plus placebo divalproex ER

PLACEBO COMPARATOR

Participants will take active lamotrigine and placebo

Drug: Lamotrigine; Drug: Placebo

Interventions

Lamotrigine DRUG

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.

Also known as: Lamictal, (LAM)

lamotrigine plus divalproex ER; lamotrigine plus placebo divalproex ER

Divalproex (DIV) ER DRUG

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.

Also known as: Depakote ER, valproic Acid

lamotrigine plus divalproex ER

Placebo DRUG

During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.

Also known as: PBO

lamotrigine plus placebo divalproex ER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of liver disease
• History of substance abuse
• Previous treatment with lamotrigine or divalproex
• Lamotrigine or divalproex intolerance

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (1)

• Bowden CL, Singh V, Weisler R, Thompson P, Chang X, Quinones M, Mintz J. Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression. Acta Psychiatr Scand. 2012 Nov;126(5):342-50. doi: 10.1111/j.1600-0447.2012.01890.x. Epub 2012 Jun 18.

  PMID: 22708645 RESULT

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Lamotrigine; lipoarabinomannan; Valproic Acid

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Charles L. Bowden, M.D. Clinical Professor
• Organization: University of Texas Health Science Center San Antonio

bowdenc@uthscsa.edu

210 567 5405

Study Officials

• Charles L. Bowden, MD

  210-567-5405

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2004
• Primary Completion: February 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 17, 2017
• Results First Posted: April 20, 2015

Record last verified: 2017-04