Schizophrenia Clinical Trial
— ANCHOR 112Official title:
A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviated)
| Verified date | January 2013 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to demonstrate efficacy and safety of quetiapine fumarate (SEROQUEL) compared with placebo in the treatment of adolescent patients with schizophrenia.
| Status | Completed |
| Enrollment | 249 |
| Est. completion date | June 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 13 Years to 17 Years |
| Eligibility |
Inclusion Criteria: - Patient is able to provide written assent and the parents or legal guardian of the patient is able to provide written informed consent before beginning and study related procedures - Patient has a documented clinical diagnosis of schizophrenia - Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit Exclusion Criteria: - Patients (female) must not be pregnant or lactating - Patients with a known intolerance or lack of response to previous treatment with quetiapine - Patients who have previously participated in this study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Aachen | |
| India | Research Site | Kanpur | |
| India | Research Site | Lucknow | |
| Malaysia | Research Site | Kuala Lumpur | |
| Malaysia | Research Site | Petaling Jaya | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Mandaluyong City | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Quezon City | |
| Poland | Research Site | Poznan | |
| Poland | Research Site | Torun | |
| Russian Federation | Research Site | Moscow | |
| Russian Federation | Research Site | St. Petersburg | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Novi Sad | |
| South Africa | Research Site | Pretoria | |
| Ukraine | Research Site | Kharkov | |
| Ukraine | Research Site | Kiev | |
| Ukraine | Research Site | Odessa | |
| United States | Research Site | Alamonte | Florida |
| United States | Research Site | Cerritos | California |
| United States | Research Site | Chicago | Illinois |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Cleveland | Ohio |
| United States | Research Site | Denver | Colorado |
| United States | Research Site | Dothan | Alabama |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Kirkland | Washington |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lyndhurst | Ohio |
| United States | Research Site | Memphis | Tennessee |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | New Orleans | Louisiana |
| United States | Research Site | Newton | Kansas |
| United States | Research Site | Oak Brook | Illinois |
| United States | Research Site | Oklahoma City | Oklahoma |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Riverside | California |
| United States | Research Site | Sacramento | California |
| United States | Research Site | San Diego | California |
| United States | Research Site | Virginia Beach | Virginia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Germany, India, Malaysia, Philippines, Poland, Russian Federation, Serbia, South Africa, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Compare efficacy of Quetiapine with placebo in the treatment of schizophrenia as assessed by the PANSS total score, change from baseline to Day 42 | |||
| Secondary | Compare the effect of Quetiapine with placebo in change from baseline to Day 42 level of functioning, evaluate aggression and hostility; evaluate safety and tolerability |
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