Completed PHASE3 INTERVENTIONAL 2-arm NCT00035802

A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder

A Randomized, Double-Blind, Multicenter, Placebo-Controlled 4-Week Study of the Safety and Efficacy of Topiramate in Adolescents With Acute Manic or Mixed Episodes of Bipolar I Disorder, With an Optional 6-Month Open-Label Extension

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

Conditions Affective Disorders, Psychotic Bipolar Disorder Mental Disorders Mood Disorders

Interventions Placebo Topiramate

Updated 6 times since 2017 Last updated: Jun 23, 2011 Started: Jan 31, 2002 Completion: Apr 30, 2002

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Affective Disorders, Psychotic and Bipolar Disorder and is currently completed. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. leads this study, which shows 6 recorded versions since 2002 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

6 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3

▶ Show 1 earlier version

Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jan 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

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

Data source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.