Ketamine Long Therm Follow Up Study (ket_Fol_Up)

January 18, 2020 updated by: Revital Amiaz, The Chaim Sheba Medical Center

Five Years Follow up: Add on Intravenous Ketamine for Major Depressive Disorder

Results of the study and of 5 years follow up of depressed patients who participated in the study during 2014-2015. We will locate the participants and will interview them will use the same questionnaires to evaluate their depressive symptoms. We will also measure the time to relapse.

Study Overview

Status

Unknown

Conditions

Detailed Description

Anamnestic data will be collected from the patients, in addition, depressive symptoms will be measured using Montgomery Asberg Depression Scale (MADRAS). In addition, the Clinical Global Severity Scale (CGI-S) and Clinical Global Improvement (CGI-I) were performed 2 hours after treatment. In addition, we performed to prolong the time to relapse in this patient.

Study Type

Observational

Enrollment (Anticipated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants in the ketamine study

Description

Inclusion Criteria:

  • Participants in the ketamine study

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to relapse
Time Frame: 5 years
Medications
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Chaim Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2019

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

January 18, 2020

First Submitted That Met QC Criteria

January 18, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 18, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5826-18-SMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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