Postpartum depressive disorders with or without psychotic symptoms
Conditions
Interventions
Trade Name: Seroquel 25 mg Filmtabletten
Product Name: Seroquel 25 mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentr
Sponsors
AstraZeneca GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent to take part in the study prior to enrolment. 2. Women aged ³ 18 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women with pre-existing psychotic disorder. 2. Patients with alcohol or substance abuse or dependence. 3. Patients with risk of transmitting human immune-deficiency virus (HIV) or hepatitis B, via blood or other body fluids (as judged by the investigator). 4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others. 5. Patients with a history of non-compliance (as judged by the investigator). 6. Evidence of clinical relevant disease 7. Clinically significant deviation from the reference range in clinical laboratory test results at enrolment ( as judged by the investigator). 8. ECG considered to show clinically significant abnormality at enrolment (as determined by the cardiologist and judged by the investigator). 9. A thyroid-stimulating hormone (TSH) concentration more than 10% above the upper limit of the normal range of the laboratory used for sample analysis at enrolment, whether or not the subject is being treated for hypothyroidism. 10. Use of Antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive drugs within 48 hours before involvement and throughout the study (except medications specified in the protocol). 11. Use of drugs that induce or inhibit the hepatic metabolising cyp3A4 enzymes within 2 weeks prior to enrolment 12. Patients who are pregnant or lactating 13. Known intolerance or lack of response to quetiapine 14. Neutropenia with an absolute neutrophile count (ANC) of £1.5 x 109 per litter. 15. Patients with unstable diabetes mellitus (DM)/HbA1c 16. Participation in another drug trial within 4 weeks prior enrolment into this study 17. Previous enrolment in the present study 18. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main (primary) objective of this study is to evaluate the efficacy of quetiapine in the treatment of postpartum depressive disorders in female patients with or without psychotic symptoms. The corresponding primary endpoint is the change in the Hamilton rating scale for depression (HAM-D) from baseline (day 1, visit 1) to week 28 (visit 13).;Secondary Objective: Efficacy: The secondary objectives of this study are to evaluate the effect of quetiapine on depression using the Hamilton rating scale for depression (HAM-D), the Clinical Global Impression (CGI), the Global Assessment of Functioning (GAF), the Montgomery Asberg Depression Rating scale (MADRS), the Brief Psychiatric Rating Scale (BPRS) and the Parental Bonding Questionnaire (PBQ) from baseline to different time points during the study and to week 28. Safety and Tolerability: To determine whether quetiapine is safe and well tolerated as assessed by number and type of adverse events, clinically significant changes in ECG (reported as AE), occurrence of EPS (reported as AE), changes in vital signs and weight, clinically significant changes in prolactin and oestrogen values and clinically significant changes in laboratory values. ;Primary end point(s): The primary endpoint is change in the Hamilton Rating Scale for Depression (HAM-D) from baseline (day 1) to week 28. | — |
Countries
Germany
Outcome results
None listed