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Ketamine IV Classic Protocol : Five Years Follow up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04824157
Recruitment Status : Completed
First Posted : April 1, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Revital Amiaz, Sheba Medical Center

Study Description
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Brief Summary:
Patients who suffer from MDD recieved ketamnie (2014-15) in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.

Condition or disease Intervention/treatment
Major Depressive Disorder Drug Abuse Medications Relapse Other: Non

Detailed Description:
Patients who suffer from Major Depressive disorder and are outpatients in our clinic and, received in the years (2014-15) ketamine in open study will be addressed and there depression mood will be evaluated using the rating scale that were used in the original research. In addition time of relapse and questions about their medications and drug use will be performed.
Study Design
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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Ketamine IV Classic Protocol : Five Years Follow up Clinical Evaluation.
Actual Study Start Date : August 8, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Groups and Cohorts
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Intervention Details:
  • Other: Non
    Follow up

Outcome Measures
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Primary Outcome Measures :
  1. Mood that will be evaluated using the MADRAS Montgomery-Asberg Depression Rating Scale". [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient who participated in ketamine study 1126 and are willing to participate
Criteria

Inclusion Criteria:

  • Patient who participated in ketamine study 1126

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT04824157


Locations
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Israel
The Chaim Sheba Medical Center
Tel HaShomer, Israel, 52621
Sponsors and Collaborators
Sheba Medical Center
More Information
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Responsible Party: Dr. Revital Amiaz, Head of Department Psychiatry B, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04824157    
Other Study ID Numbers: 5826-18-SMC
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share data with other resarchers that will be interested.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Up to 6 weeks from demand
Access Criteria: Six weeks

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Revital Amiaz, Sheba Medical Center:
Major depressive disorder
ketamine
follow up
Antidepressants
Additional relevant MeSH terms:
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Substance-Related Disorders
Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms
Chemically-Induced Disorders