Postpartum Depressive Disorder Clinical Trial
Official title:
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms
| Verified date | December 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Federal Institute for Drugs and Medical Devices |
| Study type | Interventional |
The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | October 2008 |
| Est. primary completion date | October 2008 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 39 Years |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Research Site | Herten | Westfalen-Lippe |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |