Lamotrigine Monotherapy in Pediatric Bipolar Disorder

NCT00176228 | Completed Phase 2 Results DMC

• 1 other identifier: 2003-04
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

There are two purposes for this project. Study 1 is intended to study the safety and efficacy of Lamotrigine in stabilizing the mood in all phases of pediatric bipolar disorder (Phases: mixed, manic, hypomanic, or depressed episodes) in 8-17 year old children. These children and adolescents must be treatment resistant (who failed on two adequate trials of mood stabilizing medications) to qualify for this study. Study 2 is aimed at examining brain activity and/or dysfunction before lamotrigine treatment, and to look for any alteration after lamotrigine treatment. Brain systems associated with attention and emotional processing will targeted.

Conditions

Bipolar Disorder

Outcome Measures

Primary Outcomes (1)

• Young Mania Rating Scale (YMRS),

  This measure has 11 items. The purpose of each item is to rate the severity of that abnormality in the patient. A severity rating is assigned to each of the eleven items, based on the patient's subjective report of his or her condition over the previous forty-eight hours and the clinician's behavioral observations during the interview, with the emphasis on the latter. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Total score of zero to 60 is possible, zero being normal and 60 being severe, 12 serving as a cut off point for illness if equal or above. There are several ways to show change in outcome. The mean and standard deviation at week 0, 8 and 14 will indicate if there is a change in the scores with the treatment.

  Weekly during the 8 week lamotrigine dose titration and 6 week full dose phase.

Secondary Outcomes (1)

• Child Depression Rating Scale (CDRS-R)

  weekly at baseline and each week during osing (8 weeks) and dose stabilized phase (6 weeks)

Study Arms (1)

lamotrigine

EXPERIMENTAL

The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg. Increasing the medication to final dose will take 8 weeks and the response on full and tolerable dose is further monitored for response over 6 weeks. Therefore, this is a 18-26 week trial (2 to 12 weeks=screening and wash out; 8 weeks=dosing; 6 weeks=acute trial period on full dose).

Drug: Lamotrigine

Interventions

Lamotrigine DRUG

It is a mood stabilizer that is clinically the first choice if patients present with depression and is effective in adults for mania in maintenance phase. So it is administered to see how effective it is in children and adolescents. The dose of lamotrigine will be 12.5 mg per day beginning the first day. It is increased in 12.5 mg increments every week until it reaches 50 mg and 25 mg per week of increment thereafter until maximum dose of 150 mg in those below 50 kg and 200-400 mg depending on clinical response in those above 50 kg.

Also known as: Lamictal

lamotrigine

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 10-20
• Must be able to swallow tablets
• Must be diagnosed with bipolar disorder

You may not qualify if:

• Children with general medical condition such as head injury, epilepsy, endocrine disorders
• Those who are on mood altering medications such as steroids, and those diagnosed with mental retardation are excluded to avoid confounding and contributing factors to mood swings.
• If we discover during the interview that the parent and/or child does not understand the consent/assent procedures, we will exclude them.
• Girls who are pregnant or plan to become pregnant during the study period will also be excluded from the research. There have been no concerns raised in the literature about the need for birth control practices in males treated with lamotrigine. As such, there are no provisions to exclude males from the research who do not practice birth control.
• For the fMRI study:
• Given the limited size of the magnet bore, individuals with a body weight over two-hundred and fifty pounds will be unable to be tested within the MRI scanner.
• Women in the latter stages of pregnancy may be excluded due to large body size and potential discomfort while in the MRI apparatus. Please note that girls who are taking part in the drug portion of the study (this includes all female subjects except the 5 healthy adult, control women) will be given 3 pregnancy during the drug study. This is to rule out pregnancy since pregnant girls should not be taking the study medications for safety reasons.
• Standard contraindications for fMRI studies include: cardiac pacemaker, aneurysm clip, cochlear implants, shrapnel, history of metal fragments in eyes, claustrophobia
• Participants with an IQ of less than 70 (assessed by WRAT) are likely to be excluded due to difficulties comprehending tasks and procedures

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

NPI, University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Pavuluri MN, Passarotti AM, Harral EM, Sweeney JA. Enhanced prefrontal function with pharmacotherapy on a response inhibition task in adolescent bipolar disorder. J Clin Psychiatry. 2010 Nov;71(11):1526-34. doi: 10.4088/JCP.09m05504yel. Epub 2010 Aug 24.

  PMID: 20816040 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Mani Pavuluri
• Organization: Uillinois

mpavuluri@psych.uic.edu

312 4130064

Study Officials

• Mani Pavuluri, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Psychiatry

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: February 1, 2004
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: July 30, 2015
• Results First Posted: July 30, 2015

Record last verified: 2015-06

Locations

US (1)