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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00206115
Other study ID # D1444C00132
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated January 3, 2013
Start date November 2004
Est. completion date December 2005

Study information

Verified date January 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationBulgaria: Bulgarian Drug AgencyGreece: National Organization of MedicinesIndia: Ministry of HealthPhilippines: Bureau of Food and DrugsRomania: State Institute for Drug ControlRussia: Pharmacological Committee, Ministry of HealthSouth Africa: Medicines Control Council
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 535
Est. completion date December 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Seroquel Sustained Release (SR)

Seroquel Immediate Release (IR)

Placebo


Locations

Country Name City State
Bulgaria Research Site Burgas
Bulgaria Research Site Russe
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia- Novi Iskar
Greece Research Site Athens
Greece Research Site Chania
Greece Research Site Corfu
Greece Research Site Thessaloniki
India Research Site Chennai
India Research Site Karnataka
India Research Site Lucknow
India Research Site New Delhi
Indonesia Research Site Bandung West Java
Indonesia Research Site Jakarta DKI Jakarta
Indonesia Research Site Surabaya
Philippines Research Site Cebu
Philippines Research Site Davao City
Philippines Research Site Mandaluyong City
Philippines Research Site Manila
Philippines Research Site Pasig
Romania Research Site Brasov
Romania Research Site Bucharest
Romania Research Site Bucuresti
Russian Federation Research Site Moscow
Russian Federation Research Site St. Petersburg
South Africa Research Site Bloemfontein
South Africa Research Site Ga-Rankuwa
South Africa Research Site Johannesburg
South Africa Research Site Johannesburg Gauteng
South Africa Research Site Lyttelton Manor
South Africa Research Site Medunsa Pretoria
South Africa Research Site Pretoria

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Greece,  India,  Indonesia,  Philippines,  Romania,  Russian Federation,  South Africa, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Efficacy
Secondary To demonstrate a higher PANSS response rate
Secondary To demonstrate superior Clinical Global Impressions (CGI) response
See also
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Completed NCT00018837 - Brief Hospitalization for Schizophrenia: Strategies to Improve Treatment Outcome N/A