Clinical trial NCT00457899: Rapid Versus Conventional Titration of Quetiapine in Schizophrenia/Schizoaffective Disorder
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Schizoaffective Disorders
Psychotic Disorders
Keywords: schizophrenia
schizoaffective disorder
quetiapine
seroquel
titration
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 234
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 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.


Eligibility 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.

Primary outcomes:
measure: The primary outcome variable of this study is change from baseline in total PANSS score
timeFrame: at Day 7
Secondary outcomes:
measure: Change from baseline in total PANSS scores
timeFrame: on day 5 and 14
measure: change from baseline in CGI-S and absolute CGI-I
timeFrame: on days 5, 7 and 14
measure: frequency and severity of adverse events; change in vital signs.
timeFrame: assessed at each visit
measure: change from baseline in subscale PANSS and PANSS-EC scores
timeFrame: on days 5, 7 and 14
Other outcomes:
Locations:
city: Brentwood
country: United Kingdom
facility: Research Site
state: Essex
city: Harrow
country: United Kingdom
facility: Research Site
state: Middlesex
city: Surbiton
country: United Kingdom
facility: Research Site
state: Surrey
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bognor Regis
country: United Kingdom
facility: Research Site
city: Bury St Edmunds
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Crewe
country: United Kingdom
facility: Research Site
city: Darlington
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Sandbach
country: United Kingdom
facility: Research Site
city: Warrington
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca UK
name: AstraZeneca UK Medical Director, MD
role: STUDY_DIRECTOR
affiliation: St Tydfil's Hospital
name: Professor Gary Sullivan, MD
role: PRINCIPAL_INVESTIGATOR
References: