Status:
COMPLETED
Olanzapine Compared to Lamotrigine in the Prevention of Depressive Episode in the Patients With Bipolar Disorder
Lead Sponsor:
Tri-Service General Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
15-50 years
Phase:
PHASE4
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 pr...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01864551
Start Date
August 1 2008
End Date
September 1 2012
Last Update
May 29 2013
Active Locations (1)
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1
Tri-Service General Hospital
Taipei, Taiwan, 114