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Low recruitment, completion of funding cycle
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The purpose of this project is to assess the effectiveness of preventative antidepressants immediately following delivery on postpartum depression rates in women at high risk due to prior history of depression or postpartum depression.
Eligible women for our study would be identified antepartum from our three obstetrical groups delivering at Cooper University Hospital: Cooper Faculty Group, Women's Care Center, and CamCare. Potentially eligible women would be referred to the study coordinator or principal investigator to discuss the nature of the study. Those women who agreed to the trial would be further screened with a baseline structured psychiatric evaluation in the third trimester of the pregnancy to rule-out current depressive illness. If there was no evidence of depression at the antepartum evaluation, patients delivering a liveborn singleton fetus at 34 0/7 weeks or greater would be re-evaluated prior to discharge and, if scoring \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertraline | Experimental | Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper |
|
| Placebo | Placebo Comparator | Identical appearing capsule daily containing color-matched cellulose only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertraline | Drug | Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital | Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment 0 = No postpartum depression up to 12 weeks following discharge from hospital 1 = Postpartum depression up to 12 weeks following discharge from hospital | Discharge from hospital to 12 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital | The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens | Discharge from hospital to 12 weeks postpartum |
| Reported Infant Weight at 4 Weeks Following Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Fischer, M.D. | Cooper Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cooper University Hospital | Camden | New Jersey | 08103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16467545 | Background | Chambers CD, Hernandez-Diaz S, Van Marter LJ, Werler MM, Louik C, Jones KL, Mitchell AA. Selective serotonin-reuptake inhibitors and risk of persistent pulmonary hypertension of the newborn. N Engl J Med. 2006 Feb 9;354(6):579-87. doi: 10.1056/NEJMoa052744. | |
| 11856657 | Background | Gold LH. Postpartum disorders in primary care: diagnosis and treatment. Prim Care. 2002 Mar;29(1):27-41, vi. doi: 10.1016/s0095-4543(03)00072-1. |
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Only aggregate data to be reported
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| ID | Title | Description |
|---|---|---|
| FG000 | Sertraline | Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper |
| FG001 | Placebo | Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Sertraline | Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Development of Postpartum Depression up to 12 Weeks Following Discharge From Hospital | Patients met with single psychiatrist (co-investigator), blinded to group assignment, who evaluated the patient using Edinburgh Postpartum Depression Screen, Hamilton Depression Rating Scale, Global Assessment of Functioning Scale, and clinical assessment 0 = No postpartum depression up to 12 weeks following discharge from hospital 1 = Postpartum depression up to 12 weeks following discharge from hospital | Posted | Count of Participants | Participants | Discharge from hospital to 12 weeks postpartum |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sertraline | Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard L Fischer | Cooper University Health System | 856-342-2491 | fischer-richard@cooperhealth.edu |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020280 | Sertraline |
| ID | Term |
|---|---|
| D015057 | 1-Naphthylamine |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| Placebo | Drug | Capsule containing cellulose powder of same color as experimental arm |
|
|
| 4 weeks postpartum |
| Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum | 4 weeks postpartum |
| Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum | 4 weeks postpartum |
| Reported Infant Weight at 8 Weeks Following Delivery | 8 weeks postpartum |
| Reported Infant Weight at 12 Weeks Following Delivery | 12 weeks postpartum |
| Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum | 8 weeks postpartum |
| Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum | 12 weeks postpartum |
| Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum | 8 weeks postpartum |
| Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum | 12 weeks postpartum |
| 18378767 | Background | ACOG Committee on Practice Bulletins--Obstetrics. ACOG Practice Bulletin: Clinical management guidelines for obstetrician-gynecologists number 92, April 2008 (replaces practice bulletin number 87, November 2007). Use of psychiatric medications during pregnancy and lactation. Obstet Gynecol. 2008 Apr;111(4):1001-20. doi: 10.1097/AOG.0b013e31816fd910. No abstract available. |
| 15846711 | Background | Howard LM, Hoffbrand S, Henshaw C, Boath L, Bradley E. Antidepressant prevention of postnatal depression. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD004363. doi: 10.1002/14651858.CD004363.pub2. |
| 16319254 | Background | Malm H, Klaukka T, Neuvonen PJ. Risks associated with selective serotonin reuptake inhibitors in pregnancy. Obstet Gynecol. 2005 Dec;106(6):1289-96. doi: 10.1097/01.AOG.0000187302.61812.53. |
| 15900008 | Background | Moses-Kolko EL, Bogen D, Perel J, Bregar A, Uhl K, Levin B, Wisner KL. Neonatal signs after late in utero exposure to serotonin reuptake inhibitors: literature review and implications for clinical applications. JAMA. 2005 May 18;293(19):2372-83. doi: 10.1001/jama.293.19.2372. |
| 17728416 | Background | Payne JL. Antidepressant use in the postpartum period: practical considerations. Am J Psychiatry. 2007 Sep;164(9):1329-32. doi: 10.1176/appi.ajp.2007.07030390. No abstract available. |
| 19318144 | Background | Pearlstein T, Howard M, Salisbury A, Zlotnick C. Postpartum depression. Am J Obstet Gynecol. 2009 Apr;200(4):357-64. doi: 10.1016/j.ajog.2008.11.033. |
| 19008787 | Background | Safety of SSRIs in Pregnancy. Med Lett Drugs Ther. 2008 Nov 17;50(1299):89-91. No abstract available. |
| 15705457 | Background | Sanz EJ, De-las-Cuevas C, Kiuru A, Bate A, Edwards R. Selective serotonin reuptake inhibitors in pregnant women and neonatal withdrawal syndrome: a database analysis. Lancet. 2005 Feb 5-11;365(9458):482-7. doi: 10.1016/S0140-6736(05)17865-9. |
| 15229064 | Background | Wisner KL, Perel JM, Peindl KS, Hanusa BH, Piontek CM, Findling RL. Prevention of postpartum depression: a pilot randomized clinical trial. Am J Psychiatry. 2004 Jul;161(7):1290-2. doi: 10.1176/appi.ajp.161.7.1290. |
| 11247106 | Background | Wisner KL, Perel JM, Peindl KS, Hanusa BH, Findling RL, Rapport D. Prevention of recurrent postpartum depression: a randomized clinical trial. J Clin Psychiatry. 2001 Feb;62(2):82-6. doi: 10.4088/jcp.v62n0202. |
| 19701065 | Background | Yonkers KA, Wisner KL, Stewart DE, Oberlander TF, Dell DL, Stotland N, Ramin S, Chaudron L, Lockwood C. The management of depression during pregnancy: a report from the American Psychiatric Association and the American College of Obstetricians and Gynecologists. Obstet Gynecol. 2009 Sep;114(3):703-713. doi: 10.1097/AOG.0b013e3181ba0632. |
| Placebo |
Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm |
|
|
| Secondary | Number of Participants With Adverse Reaction to Treatment Agent up to 12 Weeks Following Discharge From Hospital | The Antidepressant Side-Effect Checklist (ASEC) was employed to detect any adverse reaction to treatment regimens | Posted | Count of Participants | Participants | Discharge from hospital to 12 weeks postpartum |
|
|
|
| Secondary | Reported Infant Weight at 4 Weeks Following Delivery | Posted | Mean | Full Range | Grams | 4 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Sleeping Difficulty at 4 Weeks Postpartum | Posted | Count of Participants | Participants | 4 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Feeding Difficulties 4 Weeks Postpartum | Posted | Count of Participants | Participants | 4 weeks postpartum |
|
|
|
| Secondary | Reported Infant Weight at 8 Weeks Following Delivery | Posted | Mean | Full Range | Grams | 8 weeks postpartum |
|
|
|
| Secondary | Reported Infant Weight at 12 Weeks Following Delivery | Posted | Mean | Full Range | Grams | 12 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Sleeping Difficulty at 8 Weeks Postpartum | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Sleeping Difficulty at 12 Weeks Postpartum | Posted | Count of Participants | Participants | 12 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Feeding Difficulties 8 Weeks Postpartum | Posted | Count of Participants | Participants | 8 weeks postpartum |
|
|
|
| Secondary | Number of Participants With Perceived Infant Feeding Difficulties 12 Weeks Postpartum | Posted | Count of Participants | Participants | 12 weeks postpartum |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo | Identical appearing capsule daily containing color-matched cellulose only Placebo: Capsule containing cellulose powder of same color as experimental arm | 0 | 1 | 0 | 1 | 1 | 1 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011083 | Polycyclic Compounds |