The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorders with or without Psychotic Symptoms

• Conditions: Postpartum depressive disorders with or without psychotic symptoms

• Registration Number: EUCTR2006-006427-39-DE
• Lead Sponsor: AstraZeneca GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1.Provision of written informed consent to take part in the study prior to enrolment.
2.Women aged ³ 18 to < 40 years
3.Female patients with severe postpartum (maximum: 12 months postpartum) depressive disorders with a minimum HAM-D cut-off score of 20 points receiving at the start of the study inpatient hospital care at the Mother-Baby-Unit of the Westphalia Centre of Herten.
4.Patients who have weaned/are about to wean and do no longer breast-feed their child
5.In- or outpatients during the course of the study
6.Patients must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control.
7.Be able to understand and comply with the requirements of the study, as judged by the investigator

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified