A Study to Evaluate Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO™ (Brexanolone)
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|ClinicalTrials.gov Identifier: NCT04273191|
Recruitment Status : Withdrawn (Sage Therapeutics has decided not to proceed with this study at this time)
First Posted : February 18, 2020
Last Update Posted : August 18, 2020
Information provided by (Responsible Party):
In this Phase 4 study, women who have been prescribed commercial ZULRESSO™ (brexanolone) by a physician as standard of care for postpartum depression (PPD) and who are planning to receive the infusion per United States Prescribing Information (USPI) at a Risk Evaluation and Mitigation Strategy (REMS)-certified healthcare center are being asked to participate to collect data on multimodal neuroimaging parameters in order to evaluate the relationship between changes in depressive symptoms and changes in neuroimaging parameters.
|Condition or disease||Intervention/treatment||Phase|
|Postpartum Depression||Drug: Brexanolone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of Multimodal Neuroimaging Parameters in Women With Postpartum Depression Who Are Receiving ZULRESSO|
|Estimated Study Start Date :||February 2020|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Participants will receive a single dose of commercial brexanolone as part of standard of care.
Brexanolone will be initiated and administered per the USPI and the associated REMS.
Primary Outcome Measures :
- Change from Baseline to Post-Infusion on the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score [ Time Frame: Up to approximately 5 days ]The HAM-D total score comprises a sum of 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early night, middle night, early morning), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. Items scored in a range of 0 to 4 include: agitation, depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score can range from 0 to 52.
- Change from Baseline to Post-Infusion in Functional Connectivity Using Blood Oxygenation Level-Dependent (BOLD) Resting State Functional Magnetic Resonance Imaging (rsfMRI) [ Time Frame: Up to approximately 5 days ]rsfMRI is used in brain mapping to evaluate regional interactions that occur in a resting or task-negative state, when an explicit task is not being performed.
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