Postpartum Depressive Disorder
Conditions
Keywords
Postpartum Depression, Quetiapine, Psychotic Symptoms
Brief summary
The purpose of the study is to evaluate the efficacy and tolerability of quetiapine in female patients with postpartum depressive disorder with psychotic symptoms
Interventions
DRUGQuetiapine
150-800 mg, oral, twice a day (bid)
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in the Hamilton Rating Scale for Depression (HAM-D) | Baseline Day 1 to final visit 28 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Efficacy Scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating Scale (MADRS), Brief Psychiatric Rating Scale (BPRS) | Baseline Day 1 to final visit 28 weeks | 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 |
| Change in Functional Outcome: Global Assessment of Functioning (GAF), Parental Bonding Questionnaire (PBQ) | Baseline Day 1 to final visit 28 weeks | 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 |
| Electrocardiogram (ECG), Vital Signs, Laboratory | Baseline Day 1 to final visit 28 weeks | Safety parameter:s electrocardiogram (ECG), vital signs, laboratory no participants analysed - terminated study |
Countries
Germany
Participant flow
Recruitment details
Study period July 2007 to October 2008; Medical Clinic - Westfälischen Zentrums Herten; Psychiatrie and Psychotherapie
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine Fumarate 150 - 800mg Quetiapine fumarate, tablets, 150 - 800mg oral, per day, until 28 weeks | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Quetiapine Fumarate 150 - 800mg |
|---|---|
| Age, Customized 18 to < 40 years | 5 Participants |
| Age, Customized >= 65 years | 0 Participants |
| Age, Customized Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / — |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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
Time frame: Baseline Day 1 to final visit 28 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Fumarate | The Change in the Hamilton Rating Scale for Depression (HAM-D) | 21 scores on a HAM-D scale |
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
Time frame: Baseline Day 1 to final visit 28 weeks
Population: Data not analyzed, study terminated
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
Time frame: Baseline Day 1 to final visit 28 weeks
Population: Data not analyzed, study terminated
Secondary
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
Population: Data not analyzed, study terminated