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

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Lamotrigine
Olanzapine
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

lamotrigine

olanzapine

Arm Description

maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine

maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine

Outcomes

Primary Outcome Measures

time period to the recurrence of depressive episode
comparison of the time period to recurrent depressive episode between two groups

Secondary Outcome Measures

the recurrent depressive episode
if there is any depressive episode during follow-up period

Full Information

First Posted
May 3, 2013
Last Updated
May 24, 2013
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01864551
Brief Title
Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder
Acronym
OCTLPODEPWBD
Official Title
Comparison of Olanzapine and Lamotrigine in the Prevention of Recurrence of Depressive Episode in the Patients With Bipolar Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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..
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lamotrigine
Arm Type
Active Comparator
Arm Description
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Arm Title
olanzapine
Arm Type
Active Comparator
Arm Description
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Intervention Type
Drug
Intervention Name(s)
Lamotrigine
Other Intervention Name(s)
lamictal
Intervention Type
Drug
Intervention Name(s)
Olanzapine
Primary Outcome Measure Information:
Title
time period to the recurrence of depressive episode
Description
comparison of the time period to recurrent depressive episode between two groups
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the recurrent depressive episode
Description
if there is any depressive episode during follow-up period
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: The patients are not willing to participate in the study after detailed explanation. The patients who could not followed the investigators' instruction The patients who have severe neurological or mental illness like epileptic disorder, history of stroke, schizophrenia, schizoaffective disorder, mental retardation or uncontrolled suicide risk. The patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, history of heart attack, uncontrolled hypertension. The patient who are taking other mood stabilizers or antipsychotics within one month prior to the evaluation of entering our study. The patients who are taking medications that might interfere with the metabolism of olanzapine or lamotrigine. The patient who are allergy to olanzapine or lamotrigine.
Facility Information:
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
24885966
Citation
Pan PY, Lee MS, Lo MC, Yang EL, Yeh CB. Olanzapine is superior to lamotrigine in the prevention of bipolar depression: a naturalistic observational study. BMC Psychiatry. 2014 May 19;14:145. doi: 10.1186/1471-244X-14-145.
Results Reference
derived

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

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