Ketamine IV Classic Protocol : Five Years Follow up

• ClinicalTrials.gov Identifier: NCT04824157
• Recruitment Status: Completed
• First Posted: April 1, 2021
• Last Update Posted: April 1, 2021
• Sponsor: Sheba Medical Center
• Information provided by (Responsible Party): Dr. Revital Amiaz, Sheba Medical Center

Tracking Information

• First Submitted Date: December 23, 2019
• First Posted Date: April 1, 2021
• Last Update Posted Date: April 1, 2021
• Actual Study Start Date: August 8, 2019
• Actual Primary Completion Date: February 28, 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 30, 2021): Mood that will be evaluated using the MADRAS Montgomery-Asberg Depression Rating Scale". [ Time Frame: 6 months ]
• 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 IV Classic Protocol : Five Years Follow up
• Official Title: Ketamine IV Classic Protocol : Five Years Follow up Clinical Evaluation.
• 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.
• 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 Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patient who participated in ketamine study 1126 and are willing to participate

Condition

• Major Depressive Disorder
• Drug Abuse
• Medications
• Relapse

Intervention

Other: Non

Follow up

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2021): 11
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 30, 2020
• Actual Primary Completion Date: February 28, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient who participated in ketamine study 1126

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT04824157
• Other Study ID Numbers: 5826-18-SMC
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: Analytic Code
• Time Frame: Up to 6 weeks from demand
• Access Criteria: Six weeks

• Responsible Party: Dr. Revital Amiaz, Sheba Medical Center
• Study Sponsor: Sheba Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sheba Medical Center
• Verification Date: March 2021