Chart Review of Patients Undergoing Ketamine Infusions

NCT ID: NCT04209296

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

891 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-03

Study Completion Date

2023-09-14

Brief Summary

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The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility principally focused on providing best practices of intravenous ketamine treatment to adult patients suffering from mental health conditions. The center focuses specifically on treating individuals suffering from major depression disorder, bipolar disorder, post-traumatic stress disorder and obsessive compulsive disorder as their primary diagnosis. Herein, this retrospective analysis aims to look at past data in order to further develop our understanding of ketamine in the use of psychiatry.

Detailed Description

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Conditions

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Major Depressive Disorder Bipolar Disorder Obsessive-Compulsive Disorder Post Traumatic Stress Disorder

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Major Depressive Disorder (MDD)

DSM-5 Diagnosis of MDD

Ketamine Hydrochloride

Intervention Type DRUG

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.

Bipolar Disorder

DSM-5 Diagnosis of Bipolar Disorder

Ketamine Hydrochloride

Intervention Type DRUG

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.

Obsessive Compulsive Disorder (OCD)

DSM-5 Diagnosis of OCD

Ketamine Hydrochloride

Intervention Type DRUG

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.

Post-traumatic Stress Disorder (PTSD)

DSM-5 Diagnosis of PTSD

Ketamine Hydrochloride

Intervention Type DRUG

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.

Interventions

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Ketamine Hydrochloride

Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Over the age of 18 years old. Patients over the age of 65 must receive additional approval to ensure safety.
2. Diagnosed with either MDD, BD, PTSD or OCD by a healthcare provider.
3. Experiencing an MDE as defined and operationalized in the DSM 5.0.
4. Individuals who may have comorbid psychiatric conditions, but the comorbid psychiatric condition can be neither the primary condition or the primary clinical concern.
5. Individuals reporting suicidal ideation will be included, as suicidal ideation is a symptom of MDE.
6. Individuals must have received at least 2 guideline concordant treatment trials with pharmacotherapeutic treatment options as suggested in the CANMAT MDD guidelines 2016, Florida Medicaid guidelines 2017, or the CANMAT ISBD guidelines for BD 2013.
7. Individuals who have received ECT or other neuromodulatory treatments will be eligible for ketamine infusion.

Exclusion Criteria

1. Individuals who meet DSM 5 criteria for a substance use and/or alcohol use disorder in the past 3 months.
2. Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/mood incongruent).
3. Individuals who are unable to consent to the treatment.
4. Individuals who are unable to adhere to the protocol in its totality (i.e., remain in the clinic post infusion for up to 2-3 hours for observation).
5. Individuals who are unable to identify a person to assure their safe transport home following ketamine infusion.
6. Individuals with symptomatic traumatic brain injury.
7. Uncontrolled medical disorders (i.e., uncontrolled and/or insufficiently treated hypertension, allergies to ketamine and/or previous intolerability of ketamine).
8. Pregnancy.
9. Medical contraindications to ketamine.
10. Patients that are over 275 lbs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brain and Cognition Discovery Foundation

OTHER

Sponsor Role lead

Responsible Party

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Roger McIntyre

Chairman and Executive Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Roger S McIntyre, MD

Role: PRINCIPAL_INVESTIGATOR

Brain and Cognition Discovery Foundation

Locations

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Canadian Rapid Treatment Centre of Excellence

Mississauga, Ontario, Canada

Site Status

Countries

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Canada

References

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Chisamore N, Danayan K, Rodrigues NB, Di Vincenzo JD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, McIntyre RS, Rosenblat JD. Real-world effectiveness of repeated intravenous ketamine infusions for treatment-resistant depression in transitional age youth. J Psychopharmacol. 2023 Aug;37(8):775-783. doi: 10.1177/02698811231171531. Epub 2023 May 16.

Reference Type DERIVED
PMID: 37194253 (View on PubMed)

Danayan K, Chisamore N, Rodrigues NB, Vincenzo JDD, Meshkat S, Doyle Z, Mansur R, Phan L, Fancy F, Chau E, Tabassum A, Kratiuk K, Arekapudi A, Teopiz KM, McIntyre RS, Rosenblat JD. Real world effectiveness of repeated ketamine infusions for treatment-resistant depression with comorbid borderline personality disorder. Psychiatry Res. 2023 May;323:115133. doi: 10.1016/j.psychres.2023.115133. Epub 2023 Mar 5.

Reference Type DERIVED
PMID: 36889160 (View on PubMed)

McIntyre RS, Rosenblat JD, Rodrigues NB, Lipsitz O, Chen-Li D, Lee JG, Nasri F, Subramaniapillai M, Kratiuk K, Wang A, Gill H, Mansur RB, Ho R, Lin K, Lee Y. The effect of intravenous ketamine on cognitive functions in adults with treatment-resistant major depressive or bipolar disorders: Results from the Canadian rapid treatment center of excellence (CRTCE). Psychiatry Res. 2021 Aug;302:113993. doi: 10.1016/j.psychres.2021.113993. Epub 2021 May 13.

Reference Type DERIVED
PMID: 34034067 (View on PubMed)

Lipsitz O, McIntyre RS, Rodrigues NB, Kaster TS, Cha DS, Brietzke E, Gill H, Nasri F, Lin K, Subramaniapillai M, Kratiuk K, Teopiz K, Lui LMW, Lee Y, Ho R, Shekotikhina M, Mansur RB, Rosenblat JD. Early symptomatic improvements as a predictor of response to repeated-dose intravenous ketamine: Results from the Canadian Rapid Treatment Center of Excellence. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110126. doi: 10.1016/j.pnpbp.2020.110126. Epub 2020 Oct 5.

Reference Type DERIVED
PMID: 33031861 (View on PubMed)

Other Identifiers

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Pro00040593

Identifier Type: -

Identifier Source: org_study_id

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