EU Clinical Trial Information System (CTIS)

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

CSR-D1449L00023_final.pdf

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

Quetiapine in Postpartum Depression

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Patient Level Data

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Research Site

The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder with Psychotic Symptoms

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

Age, Customized

Gender, Male/Female

Study termination (the study could not finalised in the planned,nor in an acceptable time).

The change in the Hamilton rating scale for depression (HAM-D)

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 efficacy scales: Clinical Global Impression (CGI), Montgomery Asberg Depression Rating scale (MADRS), Brief Psychiatric rating scale (BPRS)

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

Change in functional outcome: Global Assessment of Functioning (GAF), Parental bonding Questionnaire (PBQ)

Safety parameter:s electrocardiogram (ECG), vital signs, laboratory

no participants analysed - terminated study

Quetiapine in Postpartum Depression

Official Title

Medical condition

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Healthy volunteers

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Study type

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Study design

Verification:

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Inclusion Criteria

Documents available

CSR Synopsis

Trial Results Summaries

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