Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder (OCTLPODEPWBD)

May 24, 2013 updated by: Chin-Bin Yeh, Tri-Service General Hospital

Comparison of Olanzapine and Lamotrigine in the Prevention of Recurrence of Depressive Episode in the Patients With Bipolar Disorders

The investigators hypothesized that olanzapine will be superior to lamotrigine in the prevention of any kind of recurrence of bipolar disorder. On the other hand, lamotrigine group will have better prevention of depressive episode than olanzapine group. Meanwhile, the investigators supposed that there will be more concomitant medicine in lamictal group than olanzapine group. The comorbidity will influence the measurement of outcome such as time period of recurrence of depressive episode in both groups..

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

Bipolar disorder is a highly recurrent disease and has great impact on the function of patients. Depressive symptoms consist of more than 50% of life time during the illness and may lead to self harm or suicidal behaviors. Lamotrigine, a kind of mood stabilizer, was proved to be effective in preventing depressive episode in Bipolar disorder. However, it is still lacking evidence that monotherapy with atypical antipsychotics such as olanzapine had the efficacy of preventing the recurrence of depressive episode in the patients with bipolar disorder although it had demonstrated good prevention in manic episode of bipolar disorder.

Methods:

The investigators will enroll 60 patients who had bipolar disorder in remission state for at least two months and have already received olanzapine or lamotrigine as the maintenance treatment. The patients maintained with olanzapine will be applied to olanzapine group (N=30) whereas those maintained on lamotrigine will be applied to lamotrigine group (N=30) for one month before entering into this study. They will be followed up to 12 months. The demography data will be compared between two groups. The concomitant medicine in the maintenance period of the subjects recruited will be recorded and analyzed. The time period to recurrence of depressive episode will be compared between groups. In addition, they will investigate if there is any independent factor such as comorbid substance use disorder, alcohol use disorder, personality disorders, other psychiatric disorders (posttraumatic stress disorder, eating disorder), or medical illness correlating with higher recurrent rate of depressive episode in bipolar disorder.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 50 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The patients aged 15 to 50 who have bipolar disorder defined by the DSM-IV in remission state(YMRS<12, HAMD<7, CDR<3) for at least two months and have already received olanzapine or lamotrigine as the maintenance treatment for one month. In addition, they should have at least three hypomanic, manic, depressive or mixed episodes previously.

Exclusion Criteria:

  1. The patients are not willing to participate in the study after detailed explanation.
  2. The patients who could not followed the investigators' instruction
  3. The patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, schizoaffective disorder, mental retardation or uncontrolled suicide risk.
  4. The patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension.
  5. The patient who are taking other mood stabilizers or antipsychotics within one month prior to the evaluation of entering our study.
  6. The patients who are taking medications that might interfere with the metabolism of olanzapine or lamotrigine.
  7. The patient who are allergy to olanzapine or lamotrigine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: lamotrigine
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Lamotrigine
Other Names:
  • lamictal
Active Comparator: olanzapine
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Olanzapine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time period to the recurrence of depressive episode
Time Frame: 12 months
comparison of the time period to recurrent depressive episode between two groups
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the recurrent depressive episode
Time Frame: 12 months
if there is any depressive episode during follow-up period
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tri-Service General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 24, 2013

First Posted (Estimate)

May 29, 2013

Study Record Updates

Last Update Posted (Estimate)

May 29, 2013

Last Update Submitted That Met QC Criteria

May 24, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSGH 097-05-061

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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