NCT04824157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
1 year until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

December 23, 2019

Last Update Submit

March 30, 2021

Conditions

Major Depressive DisorderDrug AbuseMedicationsRelapse

Keywords

Major depressive disorderketaminefollow upAntidepressants

Outcome Measures

Primary Outcomes (1)

  • Mood that will be evaluated using the MADRAS Montgomery-Asberg Depression Rating Scale".

    6 months

Interventions

NonOTHER

Follow up

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient who participated in ketamine study 1126 and are willing to participate

You may qualify if:

  • Patient who participated in ketamine study 1126

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Depressive Disorder, MajorSubstance-Related DisordersRecurrence

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersChemically-Induced DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department Psychiatry B

Study Record Dates

First Submitted

December 23, 2019

First Posted

April 1, 2021

Study Start

August 8, 2019

Primary Completion

February 28, 2020

Study Completion

March 30, 2020

Last Updated

April 1, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Plan to share data with other resarchers that will be interested.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Up to 6 weeks from demand
Access Criteria
Six weeks

Locations

IL(1)