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Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

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ClinicalTrials.gov Identifier: NCT04011592
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sudhakar Selvaraj, The University of Texas Health Science Center, Houston

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.


Condition or disease Intervention/treatment Phase
Post Partum Depression Drug: Ketamine 0.5 mg/kg Drug: Ketamine 0.2 mg/kg Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg
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
single intravenous infusion of Ketamine (0.5 mg/kg)
Other Name: Ketamine Hydrochloride

Drug: Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.2 mg/kg)

Experimental: Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg
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
single intravenous infusion of Ketamine (0.5 mg/kg)
Other Name: Ketamine Hydrochloride

Drug: Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.2 mg/kg)




Primary Outcome Measures :
  1. Change in depressed mood as indicated by Hamilton Depression Rating Scale (HAM-D) score [ Time Frame: baseline, 24 hours post-injection ]
    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.


Secondary Outcome Measures :
  1. Treatment-Emergent Adverse Events [ Time Frame: 24 hours post-injection ]
  2. Change in Postnatal Depression as indicated by Edinburgh Postnatal Depression Scale (EPDS) scale [ Time Frame: baseline, 24 hours post-injection ]
    The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30. Higher scores indicate worse outcome, with a score of 10 or greater indicating depression.

  3. Change in Anxiety as indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale [ Time Frame: baseline, 24 hours post-injection ]
    The Generalized Anxiety Disorder 7-Item (GAD-7) Scale score ranges from 0 to 21, with higher scores indicating greater anxiety.

  4. Change in Depression as indicated by Patient Health Questionnaire (PHQ-9) [ Time Frame: baseline, 24 hours post-injection ]
    The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.

  5. Change in Behavioral suicidal events (Suicidal Ideation), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 24 hours post-injection ]
    The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses. The first part (Items 1-5) rates an individual's degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors". The C-SSRS outcomes are categories and have binary responses (yes/no). Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS. The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation).

  6. Change in Behavioral suicidal events (Suicidal Behavior), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: baseline, 24 hours post-injection ]
    The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response. Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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): NCT04011592


Contacts
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Contact: Sudhakar Selvaraj, MBBS, DPhil 713-486-2837 Sudhakar.Selvaraj@uth.tmc.edu
Contact: Valeria Cuellar, MD 7134862523 Valeria.A.Cuellar@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77054
Contact: Sudhakar Selvaraj, MBBS,DPhil    713-486-2837    Sudhakar.Selvaraj@uth.tmc.edu   
Contact: Valeria Cuellar, MD    7134862523    valeria.a.cuellar@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sudhakar Selvaraj, 713-486-2837 UTHealth Science Center at Houston

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Responsible Party: Sudhakar Selvaraj, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04011592     History of Changes
Other Study ID Numbers: HSC-MS-18-0416
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ketamine
Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action