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

NCT01864551 | Completed Phase 4

• 1 other identifier: TSGH 097-05-061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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..

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• time period to the recurrence of depressive episode

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

  12 months

Secondary Outcomes (1)

• the recurrent depressive episode

  12 months

Study Arms (2)

lamotrigine

ACTIVE COMPARATOR

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

Drug: Lamotrigine

olanzapine

ACTIVE COMPARATOR

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

Drug: Olanzapine

Interventions

Lamotrigine DRUG

Also known as: lamictal

lamotrigine

Olanzapine DRUG

olanzapine

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 24885966 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine; Olanzapine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 29, 2013
• Study Start: August 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2012
• Last Updated: May 29, 2013

Record last verified: 2013-05

Locations

TW (1)