Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-11-30

Brief Summary

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* To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
* To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

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Detailed Description

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1. To evaluate the efficacy and safety of LAM+existing regimen of mood stabilizer in the acute treatment of patients in a mixed state of bipolar disorder.
2. To evaluate the efficacy and of a combination of LAM+existing regimen of mood stabilizers in the maintenance treatment of patients with mixed state of bipolar disorder

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lamotrigine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B.

A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II

B.

1. Patients meeting DSM-IV diagnostic criteria for a manic/hypomanic episode with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
2. Patients meeting DSM-IV symptomatic criteria for a hypomanic/manic episode for a period of 2 days or longer, with the simultaneous presence of (or rapid alteration within minutes) of at least three DSM-IV depressive symptoms excluding psychomotor agitation or
3. Patients meeting DSM-IV criteria for a depressive episode associated with at least three DSM-IV manic/hypomanic symptoms

C.MADRS of ≥14

D.YMRS of ≥ 14

E. Age 13years to 75 years

F. Male or female

G. Outpatient

Exclusion Criteria

1. illness precluding the use of LAM
2. Alcohol/drug dependence in the past one month
3. patients with a history of a rash on LAM
4. CNS neoplasms, demyelinating diseases, degenerative neurological condition or active CNS infection
5. history of seizure, known EEG with frank paroxysmal activity, known CT of brain showing gross structural abnormalities, cerebral vascular disease by history or structural brain damage from trauma
6. patients currently taking LAM

Minimum Eligible Age

13 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No