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Trial record 48 of 1066 for:    "Depressive Disorder" [DISEASE] AND Rating AND Hamilton Depression Rating Scale

A Study to Evaluate Safety and Efficacy of SAGE-547 in Participants With Moderate Postpartum Depression (547-PPD-202C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02942017
Recruitment Status : Completed
First Posted : October 21, 2016
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Sage Therapeutics

Brief Summary:
The purpose of this study was to determine if SAGE-547 Injection infused intravenously at up to 90 μg/kg/h for 60 hours reduces depressive symptoms in participants with moderate postpartum depression (PPD) compared to placebo injection as assessed by the change from baseline in Hamilton Rating Scale for Depression (HAM-D) total score.

Condition or disease Intervention/treatment Phase
Postpartum Depression Drug: Placebo Drug: SAGE-547 90 μg/kg/h Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy, Safety, and Pharmacokinetics of SAGE-547 Injection in the Treatment of Adult Female Subjects With Severe Postpartum Depression and Adult Female Subjects With Moderate Postpartum Depression
Study Start Date : July 2016
Actual Primary Completion Date : September 17, 2017
Actual Study Completion Date : October 11, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received an infusion rate equivalent to the 90 micrograms per kilogram per hour (μg/kg/h) group.
Drug: Placebo
Intravenous infusion of matching placebo for SAGE-547.

Experimental: SAGE-547 90 μg/kg/h
Participants received a 4-hour dose titration period of 30 μg/kg/h (0 to 4 hours), then 60 μg/kg/h (4 to 24 hours), then 90 μg/kg/h (24 to 52 hours), followed by a taper to 60 μg/kg/h (52 to 56 hours), and 30 μg/kg/h (56 to 60 hours).
Drug: SAGE-547 90 μg/kg/h
Intravenous infusion of SAGE-547




Primary Outcome Measures :
  1. Change From Baseline at 60 Hours in 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score [ Time Frame: Baseline, Hour 60 ]
    The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.


Secondary Outcome Measures :
  1. Change From Baseline in HAM-D Total Score at Day 30 [ Time Frame: Baseline, Day 30 ]
    The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  2. Change From Baseline in HAM-D Total Score [ Time Frame: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 72, and Days 7, 14 and 21 ]
    The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  3. Percentage of Participants With HAM-D Response [ Time Frame: Hour 60, Days 7 and 30 ]
    The HAM-D response is defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  4. Percentage of Participants With HAM-D Remission [ Time Frame: Hour 60, Days 7 and 30 ]
    HAM-D remission is defined as having a HAM-D total score of ≤7. The HAM-D Total Score comprises a sum of the 17 individual item scores. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The Total Score can range from 0 to 52, and higher scores indicate a greater degree of depression. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  5. Change From Baseline in HAM-D Bech 6 Subscale [ Time Frame: Baseline, Hour 60, Days 7 and 30 ]
    The HAM-D Bech 6 subscale score is calculated as the sum of the following six items: Item # 1 (depressed mood), Item # 2 (feelings of guilt), Item # 7 (work and activities), Item # 8 (retardation), Item # 10 (anxiety psychic), and Item # 13 (general somatic symptoms). Each item is scored in a range of 0 to 2 or 0 to 4, with higher scores indicating a greater degree of depression. The scores were transformed to a 100-point scale with a higher score indicating a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  6. Change From Baseline in HAM-D Individual Item Scores [ Time Frame: Baseline, Hours 2, 4, 8, 12, 24, 36, 48, 60, 72, and Days 7, 14, 21, and 30 ]
    The HAM-D comprises individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following symptoms are scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicate a greater degree of depression. A negative change from baseline indicates less depression. A positive change from baseline indicates more depression.

  7. Change From Baseline at Key Time Points in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score [ Time Frame: Baseline, Hour 60, Days 7 and 30 ]
    The MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicates more severe depression. A negative change from baseline indicates less severe depression. A positive change from baseline indicates more severe depression.

  8. Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response [ Time Frame: Hour 60, Days 7 and 30 ]
    The CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). CGI-I item employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices include: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions.

  9. Change From Baseline in the Generalized Anxiety Disorder 7-Item Scale (GAD-7) Total Score [ Time Frame: Baseline, Hour 60, Days 7, 14, 21 and 30 ]
    The GAD-7 is a participant-rated, generalized anxiety symptom severity scale. Scoring for GAD-7 generalized anxiety is calculated by assigning scores of 0 = "not at all sure," 1 = "several days," 2 = "over half the days," and 3 = "nearly every day" to the response categories. The GAD-7 total score for the seven items ranges from 0 to 21, where a score of 0 to 4 = minimal anxiety, 5 to 9 = mild anxiety, 10 to 14 = moderate anxiety, and 15 to 21 = severe anxiety. The GAD-7 total score was calculated as the sum of the seven individual item scores. A negative change from baseline indicates less anxiety. A positive change from baseline indicates more anxiety.

  10. Percentage of Participants With Treatment Emergent Adverse Event (TEAE) [ Time Frame: Up to approximately 37 days ]
    An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an AE with onset on or after the start of study drug infusion, or any worsening of a pre-existing medical condition/AE with onset on or after the start of study drug infusion.

  11. Time to Change in Antidepressant Medication [ Time Frame: Up to approximately 37 days ]
    The time to first start or increase in the dose and time to first stop or decrease in the dose of any antidepressant medication.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female participants between 18 and 45 years of age with PPD, defined as those who had a major depressive episode that began no earlier than the third trimester and no later than the first four weeks following delivery, as diagnosed by Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM), 4th Edition Axis I Disorders (SCID-I), a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing), and who were ≤6 months postpartum at screening were eligible for enrollment.
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Participant either must have ceased lactating at screening; or if still lactating or actively breastfeeding at screening, agreed to temporarily cease giving breastmilk to their infant(s).
  • Participant had a major depressive episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).
  • Participant had a HAM-D total score of ≥20 and ≤25 at screening and Day 1 (prior to dosing).
  • Participant was ≤ six months postpartum.
  • Participant was amenable to intravenous therapy.

Key Exclusion Criteria:

  • Active psychosis.
  • Attempted suicide associated with index case of postpartum depression.
  • Medical history of bipolar disorder.

Note: Other protocol-defined inclusion/exclusion criteria applied.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942017


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Locations
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United States, Arizona
Sage Investigational Site
Chandler, Arizona, United States, 85226
United States, Arkansas
Sage Investigational Site
Rogers, Arkansas, United States, 72758
United States, California
Sage Investigational Site
Lemon Grove, California, United States, 91945
Sage Investigational Site
Orange, California, United States, 92868
Sage Investigational Site
Ventura, California, United States, 93003
United States, Florida
Sage Investigational Site
Gainesville, Florida, United States, 32607
Sage Investigational Site
Miami, Florida, United States, 33147
Sage Investigational Site
Miramar, Florida, United States, 33027
Sage Investigational Site
Orlando, Florida, United States, 32807
Sage Investigational Site
Pensacola, Florida, United States, 32502
Sage Investigational Site
Pinellas Park, Florida, United States, 33782
United States, Georgia
Sage Investigational Site
Atlanta, Georgia, United States, 30331
United States, Illinois
Sage Investigational Site
Hoffman Estates, Illinois, United States, 60169
United States, Kansas
Sage Investigational Site
Wichita, Kansas, United States, 67226
United States, Kentucky
Sage Investigational Site
Edgewood, Kentucky, United States, 41017
Sage Investigational Site
Owensboro, Kentucky, United States, 42303
United States, Massachusetts
Sage Investigational Site
Boston, Massachusetts, United States, 02114
United States, Mississippi
Sage Investigational Site
Flowood, Mississippi, United States, 39232
United States, New Jersey
Sage Investigational Site
Marlton, New Jersey, United States, 08053
United States, New York
Sage Investigational Site
Glen Oaks, New York, United States, 11004
United States, North Carolina
Sage Investigational Site
Chapel Hill, North Carolina, United States, 27514
Sage Investigational Site
Charlotte, North Carolina, United States, 28211
Sage Investigational Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Sage Investigational Site
Columbus, Ohio, United States, 43210
Sage Investigational Site
Dayton, Ohio, United States, 45417
United States, Pennsylvania
Sage Investigational Site
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Sage Investigational Site
Baytown, Texas, United States, 77521
Sage Investigational Site
Houston, Texas, United States, 77030
Sage Investigational Site
Houston, Texas, United States, 77058
Sage Investigational Site
Richardson, Texas, United States, 75080
Sage Investigational Site
San Antonio, Texas, United States, 78229
United States, Utah
Sage Investigational Site
Orem, Utah, United States, 84058
Sponsors and Collaborators
Sage Therapeutics
Investigators
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Study Director: Helen Colquhoun, MD Sage Therapeutics
  Study Documents (Full-Text)

Documents provided by Sage Therapeutics:
Study Protocol  [PDF] March 16, 2017
Statistical Analysis Plan  [PDF] October 27, 2017


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sage Therapeutics
ClinicalTrials.gov Identifier: NCT02942017     History of Changes
Other Study ID Numbers: 547-PPD-202 C
First Posted: October 21, 2016    Key Record Dates
Results First Posted: June 13, 2019
Last Update Posted: June 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sage Therapeutics:
Moderate Postpartum Depression
SAGE-547

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs