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CompletedNCT00223509Updated Jun 20, 2012

Lamictal As Add on Treatment in Mixed States of Bipolar Disorder

A Phase 4 interventional study of Lamotrigine in Bipolar Disorder, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 2 sites in United States. Open to participants aged 13 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-20.

Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
13 Years to 75 Years
Sex
All
01

Study summary

  • 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
Read the detailed description
  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
02

Conditions studied

  • Bipolar Disorder

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Keywords

  • mixed mania
  • lamotrigine
03

In context

Bipolar Disorder

1,601 studies on the registry are indexed under Bipolar Disorder; 254 are open to participants now.

This study's enrollment of 28 is below the median of 64 across 1,223 interventional studies indexed under Bipolar Disorder.

Browse Bipolar Disorder studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Interventions

  • DrugLamotrigine
06

What researchers measure

Primary outcomes

  1. Primary efficacy, during the first 10 weeks (acute phase) of the study, will be assessed by the proportion of patients achieving a 50% reduction of their depressive symptoms as assessed by the MADRS and a GAF

    Time frame: 12 weeks

  2. MADRS

    Time frame: 12 weeks

  3. Efficacy, during the maintenance phase of the study, will be assessed by the proportion of patients able to maintain a response, at the end of the study, as defined by

  4. MADRS total score of <14, GAF score 51. Secondary measures will include the YMRS, and CGI Bipolar version.

Secondary outcomes

  1. Secondary measures will include the YMRS, and CGI Bipolar version.

07

Study locations

2 sites
  • Univ of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
  • University of Texas Health Science Center at San Antonio
    San Antonio, Texas 78229, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00223509
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 22, 2005
Start date
Aug 2005
Primary completion
Nov 2007
Completion
Nov 2007
Last update
Jun 20, 2012

Study contacts

Vivek - Singh, MD
principal investigator · University of Texas
Charles L Bowden, MD
principal investigator · University of Texas

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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