Clinical trial NCT00206115: SR-Registration Study 1, ROW: Efficacy and Safety of Seroquel® in the Treatment of Patients With Schizophrenia
Official title: A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenic Disorder
Keywords: Schizophrenic disorder
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 535
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

Exclusion Criteria:

* Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

Primary outcomes:
measure: The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.
Secondary outcomes:
measure: Efficacy
measure: To demonstrate a higher PANSS response rate
measure: To demonstrate superior Clinical Global Impressions (CGI) response
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia- Novi Iskar
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Chania
country: Greece
facility: Research Site
city: Corfu
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Karnataka
country: India
facility: Research Site
city: Lucknow
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Jakarta
country: Indonesia
facility: Research Site
state: DKI Jakarta
city: Bandung
country: Indonesia
facility: Research Site
state: West Java
city: Surabaya
country: Indonesia
facility: Research Site
city: Cebu
country: Philippines
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Mandaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Pasig
country: Philippines
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
state: Gauteng
city: Medunsa
country: South Africa
facility: Research Site
state: Pretoria
city: Bloemfontein
country: South Africa
facility: Research Site
city: Ga-Rankuwa
country: South Africa
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Lyttelton Manor
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca CNS Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603.