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CompletedNCT00309699

Paliperidone, quetiapine, or placebo for mania in bipolarity

About this title

A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder

Read the official source — NCT00309699

Researchers compared Paliperidone ER, placebo and Quetiapine to find out how the approaches affected manic symptoms in people with bipolarity.

Medication studyAges 18–65Multiple countries
The study in practice

Understand this study

What did researchers investigate?

Researchers compared Paliperidone ER, placebo and Quetiapine to find out how the approaches affected manic symptoms in people with bipolarity.

Who was this study for?

This study was for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.

Listed locations
Cerritos and 46 more locationsSee all locations and recruitment
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Study clarity

Study information

Study start dateApril 2006
Recruitment status
Completed
Enrollment listed in the registry
493
Sponsor
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor type
Pharmaceutical company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, Greece, Lithuania, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT00309699
Official title
Show the full official title

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 in Bipolar Disorder

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Recruitment & locations

Completed

Cerritos, United States · Garden Grove, United States · Oceanside, United States

46 more locations
  • San Diego, United States
  • Bradenton, United States
  • Fort Lauderdale, United States
  • Kissimmee, United States
  • Maitland, United States
  • South Miami, United States
  • Tampa, United States
  • Chicago, United States
  • Indianapolis, United States
  • Prairie Village, United States
  • Lake Charles, United States
  • Shreveport, United States
  • Flowood, United States
  • Clementon, United States
  • Moore, United States
  • Oklahoma City, United States
  • Philadelphia, United States
  • Memphis, United States
  • Dallas, United States
  • Athens, Greece
  • Alytus, Lithuania
  • Vilnius, Lithuania
  • Kazan', Russia
  • Lipetsk, Russia
  • Moscow Region, Russia
  • Moscow Russia, Russia
  • Nizny Novgorod, Russia
  • Saratov, Russia
  • St-Petersburg Na, Russia
  • Incheon, South Korea
  • Seoul, South Korea
  • Changhua, Taiwan
  • Kaohsiung City, Taiwan
  • Taichung, Taiwan
  • Taipei, Taiwan
  • Ankara, Türkiye
  • Diyarbakır, Türkiye
  • Istanbul, Türkiye
  • Donetsk, Ukraine
  • Hlevakha, Ukraine
  • Kharkiv, Ukraine
  • Kiev, Ukraine
  • Odesa, Ukraine
  • Simferopol, Ukraine
  • Russia
  • Türkiye
FAQ

Questions about this study

What did researchers investigate?

Researchers compared Paliperidone ER, placebo and Quetiapine to find out how the approaches affected manic symptoms in people with bipolarity.

Who is behind this study?

The study sponsor is Johnson & Johnson Pharmaceutical Research & Development, L.L.C., a pharmaceutical company.

Did this study involve medication?

Yes. The study involved medication, including Placebo, Quetiapine and Paliperidone ER.

Who was this study for?

This study was for people with bipolarity. Listed age limits: 18 years to 65 years. Other eligibility criteria applied.

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