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A Study to Evaluate SAGE-217 in Subjects With Severe Postpartum Depression

2016-12-01 16:08:21 | BioPortfolio

Summary

This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of the efficacy, safety and pharmacokinetics of SAGE-217 oral solution in up to 32 adult female subjects diagnosed with severe postpartum depression.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Postpartum Depression

Intervention

SAGE-217, Placebo

Status

Not yet recruiting

Source

Sage Therapeutics

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:21-0500

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Medical and Biotech [MESH] Definitions

Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386)

Transient autoimmune thyroiditis occurring in the POSTPARTUM PERIOD. It is characterized by the presence of high titers of AUTOANTIBODIES against THYROID PEROXIDASE and THYROGLOBULIN. Clinical signs include the triphasic thyroid hormone pattern: beginning with THYROTOXICOSIS, followed with HYPOTHYROIDISM, then return to euthyroid state by 1 year postpartum.

Decompression external to the body, most often the slow lessening of external pressure on the whole body (especially in caisson workers, deep sea divers, and persons who ascend to great heights) to prevent DECOMPRESSION SICKNESS. It includes also sudden accidental decompression, but not surgical (local) decompression or decompression applied through body openings.

Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum).

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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