Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

NCT04011592 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: HSC-MS-18-0416
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community. The purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.

Conditions

Post Partum Depression

Outcome Measures

Primary Outcomes (1)

• Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score

  The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53. A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms. The value reported is the score at baseline minus the score 24 hours post-injection.

  baseline, 24 hours post-injection

Secondary Outcomes (6)

• Number of Treatment-Emergent Adverse Events

  24 hours post-injection

• Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale

  baseline, 24 hours post-injection

• Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale

  baseline, 24 hours post-injection

• Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)

  baseline, 24 hours post-injection

• Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

  baseline, 24 hours post-injection

Study Arms (2)

Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg

EXPERIMENTAL

single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)

Drug: Ketamine 0.5 mg/kg; Drug: Ketamine 0.2 mg/kg

Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg

EXPERIMENTAL

single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)

Drug: Ketamine 0.5 mg/kg; Drug: Ketamine 0.2 mg/kg

Interventions

Ketamine 0.5 mg/kg DRUG

single intravenous infusion of Ketamine (0.5 mg/kg)

Also known as: Ketamine Hydrochloride

Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg; Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg

Ketamine 0.2 mg/kg DRUG

single intravenous infusion of Ketamine (0.2 mg/kg)

Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg; Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female subjects, ages 18-45 years
• Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (\>12 EPDS or \>14 HAM-D).
• No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.
• PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.
• Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent

You may not qualify if:

• No current or past psychosis or severe personality disorder.
• No current substance abuse or dependence.
• No serious and imminent suicidal or homicidal risk.
• No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.
• Not diagnosed with cardiovascular disorders.
• No increased risk of laryngospasm or active upper respiratory infections.
• Not diagnosed with an intellectual disability or neurodegenerative diseases.
• Mothers that are currently breastfeeding.
• No current pregnancy.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Ketamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Only one subject was enrolled, and enrollment goal not met.

Results Point of Contact

• Title: Sudhakar Selvaraj, MD, PhD, Assistant Professor
• Organization: The University of Texas Health Science Center at Houston

Sudhakar.Selvaraj@uth.tmc.edu

713-486-2837

Study Officials

• Sudhakar Selvaraj, 713-486-2837

  UTHealth Science Center at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 8, 2019
• Study Start: March 4, 2019
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: October 19, 2021
• Results First Posted: September 14, 2020

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)