Low-dose S-ketamine in Women With Prenatal Depression

NCT04414943 | Completed DMC

• 1 other identifier: 2019[336]
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 7

Brief Summary

Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.

Conditions

Prenatal Depression; Ketamine; Postpartum Depression

Keywords

Prenatal Depression; S-ketamine; Postpartum Depression

Outcome Measures

Primary Outcomes (1)

• The incidence of depression at 42 days postpartum.

  Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.

  At 42 days after childbirth.

Secondary Outcomes (8)

• Maternal depression score at 7 days postpartum.

  At 7 days after childbirth.

• Maternal depression score at 42 days postpartum.

  At 42 days after childbirth.

• Maternal depression severity at 42 days postpartum.

  At 42 days after childbirth.

• Intensity of pain at 1, 7, and 42 days postpartum.

  At 1, 7, and 42 days after childbirth.

• Maternal breast feeding at 1, 7, and 42 days postpartum.

  At 1, 7, and 42 days after childbirth.

Study Arms (2)

S-katamine group

EXPERIMENTAL

For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.

Drug: S-ketamine

Placebo group

PLACEBO COMPARATOR

For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.

Drug: Placebo

Interventions

S-ketamine DRUG

For women in this group, active drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.

Also known as: S-ketamine hydrochloride

S-katamine group

Placebo DRUG

For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.

Also known as: Normal saline

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This clinical trail is based in pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age ≥18 years;
• Prenatal Edinburgh postnatal depression scale score ≥10 points.

You may not qualify if:

• A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
• Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
• American Society of Anesthesiologists classification ≥III;
• Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Peking University International Hospital: collaborator
• Hunan Provincial Maternal and Child Health Care Hospital: collaborator
• Nanjing Medical University: collaborator
• Women's Hospital School Of Medicine Zhejiang University: collaborator

Study Sites (7)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Peking University International Hospital

Beijing, Beijing Municipality, China

Location

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Huaian Maternal and Child Health Care Hospital

Huaian, Jiangsu, China

Location

Nanjing Maternal and Child Health Care Hospital

Nanjing, Jiangsu, China

Location

Women's Hospital School Of Medicine Zhejiang University

Hangzhou, Zhejiang, China

Location

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MeSH Terms

Conditions

Depression, Postpartum

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: June 1, 2020
• First Posted: June 4, 2020
• Study Start: June 19, 2020
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)