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Ketamine Infusion for Adolescent Depression and Anxiety

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ClinicalTrials.gov Identifier: NCT02579928
Recruitment Status : Completed
First Posted : October 20, 2015
Results First Posted : March 16, 2020
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
American Academy of Child Adolescent Psychiatry.
Information provided by (Responsible Party):
Yale University

Brief Summary:
The purpose of this study is to determine the tolerability and short-term efficacy of a single ketamine infusion for the treatment of adolescents with 1) medication-refractory major depressive disorder (MDD) and/or 2) medication-refractory anxiety disorders (social anxiety disorder, panic disorder, generalized anxiety disorder and/or separation anxiety disorder).

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Anxiety Disorder Drug: Ketamine Drug: Midazolam Phase 4

Detailed Description:
We will conduct a crossover trial in which as many as 36 adolescents (18 with MDD and 18 with anxiety disorders) will be given a single infusion of ketamine (study drug) or midazolam (active control). MDD symptoms and anxiety symptoms will be monitored over a two-week period. If applicable, comorbid school refusal symptoms will also be monitored over a two-week period for both cohorts. A 2-week washout period will be required between infusion doses. Our primary outcomes will be 1) improvement in MDD symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial and 2) improvement in the anxiety symptoms (measured by the Multimodal Anxiety Scale for Children (MASC) acute physical symptoms subscale) for the cohort of subjects enrolled in the anxiety disorders arm of the trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants were randomly assigned the treatment order, with participants receiving a single infusion of either ketamine hydrochloride (0.5 mg/kg) or midazolam (0.045 mg/kg) on Day 1, and the alternate compound 2 weeks later.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Midazolam was chosen as an active placebo in keeping with its similar pharmacokinetic profile and precedent as a reasonable comparator for nonspecific behavioral effects of ketamine
Primary Purpose: Treatment
Official Title: Efficacy of Rapid-Acting NMDA Antagonist for Treatment of Adolescent Depression and Anxiety Disorders
Study Start Date : October 2015
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Ketamine
Participants were randomly be assigned to receive a dose of 0.5 mg/kg of Ketamine (administered intravenously over 40 minutes with a maximum total dose allowed in this study will be 50mg).
Drug: Ketamine
A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Other Name: Ketalar

Experimental: Midazolam
Participants were randomly assigned to receive a dose of 0.045mg/kg of Midazolam (administered Intravenously over 40 minutes with a the maximum total dose allowed in this study of 4.5mg),
Drug: Midazolam
A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Other Name: Versed




Primary Outcome Measures :
  1. Montgomery-Asberg Depression Rating Scale Score 1 Day After Infusion [ Time Frame: 1 day after the infusion ]

    Depressive symptoms (measured by Montgomery-Asberg Depression Rating Scale, revised (MADRS) score) on 1 day after infusion, for the cohort of subjects enrolled in the MDD arm of this trial.

    Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

    Usual cutoff points are:

    0 to 6 - normal /symptom absent. 7 to 19 - mild depression. 20 to 34 - moderate depression. >34 - severe depression.




Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion:

MDD Cohort:

  • Meet DSM-5 criteria for Major Depressive Disorder by structured interview (MINI-KID)
  • CDRS-R score >40.
  • Failure to achieve remission with at least 1 adequate prior antidepressant trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.

Anxiety Cohort:

  • Meet DSM-5 criteria for any of the following anxiety disorders: Social Anxiety Disorders, Generalized Anxiety Disorder, Separation Anxiety Disorder and/or Panic Disorder by structured interview (MINI-KID)
  • ADIS Clinical Severity Rating ≥4 (moderately severe) for any of the 4 included anxiety disorders
  • Failure to achieve remission with at least 1 adequate prior anxiolytic medication trial (e.g. SSRI, SNRI, or TCA), meaning at least 8 weeks at therapeutic dosing, including at least 4 weeks of stable dosing.
  • Failure to achieve remission with previous CBT or subject declines current CBT therapy

Both cohorts:

  • Stable psychiatric medications and doses for the month prior to enrollment. Subjects may continue to engage in any ongoing psychotherapy.
  • Medically and neurologically healthy on the basis of physical examination and medical history.
  • Parents able to provide written informed consent and adolescents must additionally provide assent.

Exclusion:

  • Current inpatient hospitalization or active suicidal ideation requiring referral for inpatient hospitalization for safety.
  • History of psychotic disorder or manic episode diagnosed by MINI-KID
  • History of substance dependence diagnosis by MINI-KID (excluding tobacco) or positive urine toxicology.
  • Pregnancy (urine pregnancy tests on the day of scans for menstruating girls).
  • Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.

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): NCT02579928


Locations
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United States, Connecticut
Hospital Research Unit at the Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Yale Child Study Center
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
American Academy of Child Adolescent Psychiatry.
Investigators
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Principal Investigator: Michael H. Bloch, MD MS Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Publications:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02579928    
Other Study ID Numbers: 1506016041
First Posted: October 20, 2015    Key Record Dates
Results First Posted: March 16, 2020
Last Update Posted: July 14, 2020
Last Verified: June 2020
Keywords provided by Yale University:
Ketamine
Depression
Major Depressive Disorder
Anxiety
School refusal
Suicide
Generalized Anxiety
Suicidal Ideation
Additional relevant MeSH terms:
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Disease
Depression
Depressive Disorder
Anxiety Disorders
Depressive Disorder, Major
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Midazolam
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Hypnotics and Sedatives
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators