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Ketamine Long Therm Follow Up Study (ket_Fol_Up)

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ClinicalTrials.gov Identifier: NCT04238039
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
Revital Amiaz, The Chaim Sheba Medical Center

Tracking Information
First Submitted Date January 18, 2020
First Posted Date January 23, 2020
Last Update Posted Date January 23, 2020
Actual Study Start Date December 14, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2020)
Time to relapse [ Time Frame: 5 years ]
Medications
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ketamine Long Therm Follow Up Study
Official Title Five Years Follow up: Add on Intravenous Ketamine for Major Depressive Disorder
Brief Summary 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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Participants in the ketamine study
Condition Followin Ketamine Treatment
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 18, 2020)
16
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2020
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Participants in the ketamine study

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages up to 90 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT04238039
Other Study ID Numbers 5826-18-SMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party Revital Amiaz, The Chaim Sheba Medical Center
Study Sponsor The Chaim Sheba Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account The Chaim Sheba Medical Center
Verification Date January 2020