Quetiapine in Postpartum Depression

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

Official Title
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The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms

Conditions
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Postpartum Depressive Disorder

Intervention / Treatment
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* Drug: Quetiapine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quetiapine Fumarate 150 - 800mg<br>Quetiapine 150-800mg | Drug: Quetiapine<br>* 150-800 mg, oral, twice a day (bid)<br>* Other names: Seroquel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline Day 1 to final visit 28 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | Baseline Day 1 to final visit 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum Depression, Quetiapine, Psychotic Symptoms