Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder (RAPID)
This study has been terminated.
(Study terminated due to poor recruitment)
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00457899
First received: April 5, 2007
Last updated: November 26, 2007
Last verified: November 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorders Psychotic Disorders |
Drug: Quetiapine IR (Immediate Release) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- The primary outcome variable of this study is change from baseline in total PANSS score [ Time Frame: at Day 7 ]
Secondary Outcome Measures:
- Change from baseline in total PANSS scores [ Time Frame: on day 5 and 14 ]
- change from baseline in CGI-S and absolute CGI-I [ Time Frame: on days 5, 7 and 14 ]
- frequency and severity of adverse events; change in vital signs. [ Time Frame: assessed at each visit ]
- change from baseline in subscale PANSS and PANSS-EC scores [ Time Frame: on days 5, 7 and 14 ]
| Estimated Enrollment: | 234 |
| Study Start Date: | July 2007 |
| Study Completion Date: | September 2007 |
Intervention Details:
-
Drug: Quetiapine IR (Immediate Release)
oral
Other Name: Seroquel
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women, aged 18 to 65 years, who require treatment for an acute episode of schizophrenia/schizoaffective disorder as judged by their doctor
Exclusion Criteria:
- Significant and unstable conditions of hear, circulation, blood, liver, kidney; malignancies (cancer); diabetes (mellitus); history of fits or fainting. Resistance to antipsychotic medication. Current alcohol/drug abuse. Pregnant/breast feeding women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457899
Locations
| United Kingdom | |
| Research Site | |
| Brentwood, Essex, United Kingdom | |
| Research Site | |
| Harrow, Middlesex, United Kingdom | |
| Research Site | |
| Surbiton, Surrey, United Kingdom | |
| Research Site | |
| Birmingham, United Kingdom | |
| Research Site | |
| Bognor Regis, United Kingdom | |
| Research Site | |
| Bury St Edmunds, United Kingdom | |
| Research Site | |
| Coventry, United Kingdom | |
| Research Site | |
| Crewe, United Kingdom | |
| Research Site | |
| Darlington, United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Research Site | |
| Sandbach, United Kingdom | |
| Research Site | |
| Warrington, United Kingdom | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca UK Medical Director, MD | AstraZeneca UK |
| Principal Investigator: | Professor Gary Sullivan, MD | St Tydfil's Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00457899 History of Changes |
| Other Study ID Numbers: | D1443L00003 |
| Study First Received: | April 5, 2007 |
| Last Updated: | November 26, 2007 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by AstraZeneca:
|
schizophrenia schizoaffective disorder quetiapine seroquel titration |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Quetiapine Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 21, 2013