A Phase 4 interventional study of Lamotrigine and Olanzapine in Bipolar Disorder, sponsored by Tri-Service General Hospital (TSGH). Completed at 1 site in Taiwan. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-05-29.
Sponsored by Tri-Service General Hospital (TSGH) · Phase 4, Interventional, and Prevention
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..
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.
1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.
This study's enrollment of 60 is close to the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.
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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:
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Lamotrigine
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Olanzapine
Also known as: lamictal
time period to the recurrence of depressive episode
comparison of the time period to recurrent depressive episode between two groups
Time frame: 12 months
the recurrent depressive episode
if there is any depressive episode during follow-up period
Time frame: 12 months
The record gives a start of Aug 2008, a primary completion of Jul 2009 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lamotrigine · Olanzapine
Tri-Service General Hospital (TSGH)