Quetiapine in Postpartum Depression

Phase 2TerminatedNCT00681668

AstraZeneca5 enrolled

Overview

The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Postpartum Depressive Disorder

Interventions

QuetiapineDRUG

150-800 mg, oral, twice a day (bid)

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed informed consent. * Female patients with severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points Exclusion Criteria: * Woman with pre-existing psychotic disorder * Patients with alcohol or substance abuse or dependence * Patients who pose an imminent risk of suicide or danger to self or others

Locations (1)

Research Site

Herten, Westfalen-Lippe, Germany

Outcomes

Primary Outcomes

The Change in the Hamilton Rating Scale for Depression (HAM-D)

HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state

Time frame: Baseline Day 1 to final visit 28 weeks

Secondary Outcomes

Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS)

Change in efficacy scales: Clinical Global Impression (CGI),Scale of 1-7 (1 = normal or no change - 7 = extremely ill or extreme changes). Montgomery Asberg Depression Rating scale (MADRS) 10 questions with a scale of 1-4 (1 = no symptoms - 4 = severe symptoms), higher score = worst values. Brief Psychiatric rating scale (BPRS)- 24 symptom constructs, each to be rated in a 7-point scale of severity ranging from 'not present' to 'extremely severe' no participants analysed - terminated study

Time frame: Baseline Day 1 to final visit 28 weeks

Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ)

Change in functional outcome: Global Assessment of Functioning (GAF),scale of 1-100 (1 = severe symptoms - 100 = no symptoms) Parental bonding Questionnaire (PBQ) no participants analysed - terminated study

Time frame: Baseline Day 1 to final visit 28 weeks

Electrocardiogram (ECG), Vital Signs, Laboratory

Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study

Time frame: Baseline Day 1 to final visit 28 weeks

Data from ClinicalTrials.gov

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