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Anti-epileptic drug

Lamotrigine for Mania

Phase 4
Waitlist Available
Led By Janet Wozniak, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 weeks
Awards & highlights

Study Summary

The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.

Eligible Conditions
  • Mania
  • Bipolar Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Manic

Side effects data

From 2008 Phase 4 trial • 51 Patients • NCT00181844
38%
Headache
28%
Injury
21%
Vomiting
18%
Sore throat
18%
Rashes
18%
Stomach ache
15%
Nasal congestion
15%
Tooth pain
13%
Fever
13%
Fatigue
13%
Cough
10%
Rhinorhea
10%
Miscellaneous other skin lesions
10%
Nausea
10%
Dizziness
8%
Appetite loss
8%
Cold
8%
Dyspepsia
8%
Ear infection
8%
Ear pain
8%
Insomnia
8%
Itching
5%
Unsteady
5%
Shakiness
5%
Temper tantrum
5%
Eye irritation
5%
Hip dysplasia
5%
Diarrhea
5%
Jitteriness
5%
Lethargy
5%
Loss of voluntary movement
5%
Contact dermatitis
5%
Sunburn
5%
Chest pain
5%
Panic attacks
3%
Poison Ivy
3%
Acid reflux
3%
Sinus infection
3%
Upper respiratory infection
3%
Increased appetite
3%
More manic
3%
Backache
3%
GERD vomiting
3%
Malaise
3%
Menstrual cramps
3%
Nosebleed
3%
Palpitations
3%
Wheezing
3%
Bruising
3%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lamotrigine

Trial Design

1Treatment groups
Experimental Treatment
Group I: LamotrigineExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamotrigine
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,938 Previous Clinical Trials
13,199,243 Total Patients Enrolled
9 Trials studying Mania
231 Patients Enrolled for Mania
Janet Wozniak, MDPrincipal InvestigatorMassachusetts General Hospital
9 Previous Clinical Trials
374 Total Patients Enrolled
3 Trials studying Mania
132 Patients Enrolled for Mania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Janet Wozniak, MD 2005. "Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00181844.
~3 spots leftby May 2025
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