Schizophrenic Disorder Clinical Trial
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
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.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Bulgaria, Greece, India, Indonesia, Philippines, Romania, Russian Federation, South Africa,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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