A prospective 8 weeks acute phase study investigating efficacy, safety and tolerability of Quetiapine fumarate in 60 drug-naïve first-episode psychosis patients aged 18 to 35 years.
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel
Product Code: Seroquel
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine fumarate
CAS Number: 111974-72-2
Current Sponsor code: Quetia
Sponsors
Psychosis Early Detection and Intervention Centre, Department for Psychiatry, UKE Hamburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Every patient with a certain severity of illness who meets inclusion criteria for the Early Psychosis Prevention and Intervention Centre (PEDIC) may be eligible for the trial. For inclusion in the study, subject must fulfill all of the following criteria: 1. Signed study informed consent document indicating that they understand purpose of and procedures required for the study and are willing to participate in the study (sub-jects who are unable to provide their own consent will not be allowed to enroll in the study). 2. Male or female 3. Age 18-35 years 4. Psychotic symptoms longer than a week that cannot be explained by other means e.g. drug-induced or organic psychosis. 5. According to DSM-IV TR (APA 2003), subjects must have met diagnostic criteria for following diagnoses: Schizophrenia including disorganized type (295.10), catatonic type (295.20), paranoid type (295.30), or undifferentiated type (295.90) or Schizophreniform Disorder (295.40) or Schizoaffective Disorder (295.70) including manic, depressive and mixed sub-types, Delusional Disorder (297.1), Psychotic Disorder not otherwise specified (298.9). 6. Subjects must have at least one PANSS positive item score = 6 7. Subjects must have a baseline Clinical Global Impression Severity score = 5 8. Female patients at risk of pregnancy must be successfully using some form of contraception 9. Negative pregnancy test 10. Able and willing to meet or perform study requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. According to DSM-IV TR (APA 2003), subjects with following diagnoses will be ex-cluded: Bipolar Disorder (including 296.44, 296.54 and 296.64), Drug induced psychotic episode (292.1), Brief Psychotic Episode (298.8), Psychotic disorder due to a general medical condition (293.xx) 2. Antipsychotic treatment prior to study longer than 8 weeks (cumulative antipsychotic treatment) 3. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol, Mental retardation (IQ approximately lower then 70), Organic disorders presenting with a psychotic syndrome (e.g. Nieman Pick disorder, Adult-onset Tay-Sachs disorder, HIV encephalopathy, temporal lobe epilepsy) 4. History of clinically significant physical illness 5. History of epilepsy or seizures (febrile convulsions in childhood acceptable) 6. History of brain surgery 7. History of brain infarct 8. Preexisting diabetes mellitus 9. Concomitant medications that prolong the QT interval 10. Participation in any other studies involving investigational or marketed products, con-comitantly or within 30 days prior to entry in the study 11. Pregnant or lactating women, or women of childbearing potential not using an ac-ceptable method of contraception. 12. Contraindication as detailed in country specific information for quetiapine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of Quetiapine fumarate on positive psychotic symptoms measured as change of the PANSS positive subscore be-tween baseline and endpoint (8 weeks).;Secondary Objective: 1. Efficacy: Number of patients with an improvement of 20% (30 and 40%, respectively) in the PANSS positive subscore, number of patients with an improvement of 20% (30 and 40%, respectively) in the PANSS total score, significant improvement between baseline to endpoint (PANSS total score, PANSS negative subscore, PANSS disorganization factor, PANSS hostility and excitement factor, PANSS anxiety and depression factor), number of patients with an improvement of = 2 points in the CGI-S score between base-line to endpoint 2. Efficacy of Quetiapine on psychosocial functioning measured as significant improvement in the GAF total score from baseline to endpoint 3. Efficacy of Quetiapine on Quality of Life measured as significant improvement in the SF-36 total score from baseline to endpoint 4. Efficacy of Quetiapine on subjective wellbeing measured as significant improvement in the SWN total score from baseline to endpoint. 5. Tolerability 6. Safety;Primary end point(s): The primary objective of this study is to evaluate the efficacy of Quetiapine fumarate on positive psychotic symptoms measured as the change of the PANSS positive subscore between baseline to endpoint (8 weeks). | — |
Countries
Germany
Outcome results
None listed