Psychotic Disorders, Schizophrenia, Bipolar Disorder
Conditions
Keywords
acute schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), bipolar mania with psychotic symptoms
Brief summary
The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis
Interventions
DRUGQuetiapine
PROCEDURERating Scales
PROCEDURESelf Assessment Form
PROCEDUREBlood and urine samples
PROCEDURESleeping pattern
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
* provision of written informed consent * male or female, aged 18-65 years * requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode * able to swallow tablets from Day 1
Exclusion criteria
* In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5 * patients with known relevant clinical disease * history of syncope, or orthostatic hypotension * patients with known neutropenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE | — |
Countries
Sweden
Outcome results
None listed