A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I Disorder - Protocol R076477-BIM-3002 Phase 3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-005812-25-LT

Enrollment

475

Registered

2006-02-06

Start date

2006-03-07

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder

Interventions

Trade Name: Seroquel Product Name: Quetiapine 100mg overencapsulated tablet Product Code: F275 Pharmaceutical Form: Tablet INN or Proposed INN: Quetiapine Fumarate Current Sponsor code: Quetiapine Fum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Man or woman between 18 (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older) and 65 years of age; Meet DSM-IV criteria for Bipolar I Disorder, Most Recent Episode Manic or Mixed (with or without psychotic features) at the time of screening; History of at least 1 previoulsy documented manic or mixed episode requiring medical treatment within the 3 years before screening phase Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Unable to provide their own consent; Meet DSM-IV criteria other than Bipolar I Disorder; Meet DSM-IV criteria for rapid cycling and schizoaffective disorder; use of clozapine, aripiprazole, or fluoxetine within 1 month before the screening phase; Alcohol intoxication within 3 days before study drug administration on Day 1

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the study are to demonstrate the antimanic efficacy and to assess the safety of flexibly dosed paliperidone extended release (ER) compared with placebo during 3 weeks of treatment in subjects with Bipolar I Disorder who are experiencing an acute manic or mixed episode;Secondary Objective: To demonstrate that flexibly dosed paliperidone ER and quetiapine have comparable antimanic efficacy over a 12 week period; to assess the safety of flexibly dosed paliperidone ER over a 12 week period; and to assess the effect on global functioning associated with flexibly dosed paliperidone ER compared with placebo over a 3 week period;Primary end point(s): Efficacy assessments include the YMRS, GAF, CGI-BP-S, PANSS, VAS and the SF-36. The primary efficacy endpoint for this study is the change from baseline in total YMRS score at the end of the double blind, acute treatment phase	—

Measure

Time frame

Main Objective: The primary objectives of the study are to demonstrate the antimanic efficacy and to assess the safety of flexibly dosed paliperidone extended release (ER) compared with placebo during 3 weeks of treatment in subjects with Bipolar I Disorder who are experiencing an acute manic or mixed episode;Secondary Objective: To demonstrate that flexibly dosed paliperidone ER and quetiapine have comparable antimanic efficacy over a 12 week period; to assess the safety of flexibly dosed paliperidone ER over a 12 week period; and to assess the effect on global functioning associated with flexibly dosed paliperidone ER compared with placebo over a 3 week period;Primary end point(s): Efficacy assessments include the YMRS, GAF, CGI-BP-S, PANSS, VAS and the SF-36. The primary efficacy endpoint for this study is the change from baseline in total YMRS score at the end of the double blind, acute treatment phase

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Countries

Greece, Lithuania

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026