Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01864551
Recruitment Status : Completed
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Chin-Bin Yeh, Tri-Service General Hospital

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..

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lamotrigine Drug: Olanzapine Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparison of Olanzapine and Lamotrigine in the Prevention of Recurrence of Depressive Episode in the Patients With Bipolar Disorders
Study Start Date : August 2008
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Active Comparator: lamotrigine
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Lamotrigine
Other Name: lamictal

Active Comparator: olanzapine
maintenance treatment of the patients with bipolar disorder with olanzapine or lamotrigine
Drug: Olanzapine



Primary Outcome Measures :
  1. time period to the recurrence of depressive episode [ Time Frame: 12 months ]
    comparison of the time period to recurrent depressive episode between two groups


Secondary Outcome Measures :
  1. the recurrent depressive episode [ Time Frame: 12 months ]
    if there is any depressive episode during follow-up period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01864551


Locations
Layout table for location information
Taiwan
Tri-Service General Hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
Tri-Service General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chin-Bin Yeh, Attending Physician, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT01864551     History of Changes
Other Study ID Numbers: TSGH 097-05-061
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Lamotrigine
Olanzapine
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Calcium Channel Blockers
Calcium-Regulating Hormones and Agents
Sodium Channel Blockers