NCT00035802

Brief Summary

The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 6, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2002

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

First QC Date

May 6, 2002

Last Update Submit

June 23, 2011

Conditions

Bipolar DisorderAffective Disorders, PsychoticMood DisordersMental Disorders

Keywords

BipolarManiaPediatricChildrenAdolescentTopiramateAnticonvulsantsCentral Nervous System AgentsProtective AgentsNeuroprotectiive Agents

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in total Young Mania Rating Scale (YMRS) score

    Baseline to Day 28 (or last available observation prior to Day 28).

Secondary Outcomes (3)

  • Change from baseline in Clinical Global Impression Scale (CGI-S) score

    Baseline to Day 28 (or last available observation prior to Day 28).

  • Change from baseline in Children's Global Assessment Scale (C-GAS) score

    Baseline to Day 28 (or last available observation prior to Day 28).

  • The number of patients continuing to meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for manic or mixed episodes of Bipolar I Disorder

    Day 28 (or last available observation prior to Day 28)

Study Arms (2)

001

EXPERIMENTAL

Topiramate Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.

Drug: Topiramate

002

PLACEBO COMPARATOR

Placebo Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

Drug: Placebo

Interventions

TopiramateDRUG

Double-blind period: Up to 400 mg/day (two 100-mg tablets twice a day) for 28 days. OL period: Up to 600 mg/day (three 100-mg tablets twice a day) for at least 6 months.

001
PlaceboDRUG

Double-blind period: Equal number of matching placebo tablets for each of the topiramate tablet strengths twice a day for 28 days.

002

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • DSM-IV diagnosis of Bipolar I Disorder (confirmed by the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version \[K-SADS-P/L\])
  • YMRS score greater than or equal to 20
  • General good health as determined by medical history, physical examination, and laboratory evaluations
  • Ability to swallow tablets
  • Patient's parent or guardian must be fully capable of monitoring the patient's disease process and compliance to treatment
  • Parent(s) or legal guardian(s) must read and sign the informed consent form after the nature of the study has been fully explained and assent must be obtained from patients

You may not qualify if:

  • DSM-IV Axis I disorder diagnoses of autistic disorder, schizophrenia, schizoaffective disorder, or other psychotic disorders not otherwise specified (NOS)
  • Chronic antidepressant treatment within 4 weeks of randomization (5 weeks for fluoxetine), use of psychostimulants in the 7 days prior to baseline, use of any other psychotropic medications within 3 days or 5 half-lives, whichever is less, prior to baseline, or requirement for treatment with other psychotropic drugs on an ongoing basis
  • Weight less than 33 kg or current or past history of anorexia nervosa
  • Serious or unstable medical or neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bipolar DisorderAffective Disorders, PsychoticMood DisordersMental DisordersMania

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersSchizophrenia Spectrum and Other Psychotic DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2002

First Posted

May 7, 2002

Study Start

January 1, 2002

Study Completion

April 1, 2002

Last Updated

June 27, 2011

Record last verified: 2011-06