Psychotic Disorders, Schizoaffective Disorders, Schizophrenia
Conditions
Keywords
schizophrenia, schizoaffective disorder, quetiapine, seroquel, titration
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.
Interventions
DRUGQuetiapine IR (Immediate Release)
oral
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variable of this study is change from baseline in total PANSS score | at Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total PANSS scores | on day 5 and 14 |
| change from baseline in CGI-S and absolute CGI-I | on days 5, 7 and 14 |
| frequency and severity of adverse events; change in vital signs. | assessed at each visit |
| change from baseline in subscale PANSS and PANSS-EC scores | on days 5, 7 and 14 |
Countries
United Kingdom
Outcome results
None listed