Followin Ketamine Treatmentket_Fol_UpNCT04238039
Ketamine Long Therm Follow Up Study
An observational study of Followin Ketamine Treatment, run by The Chaim Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 90 years
- Conditions the study is for
- Followin Ketamine Treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Dec 2019to 1 Apr 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants in the ketamine study
Who may be able to join
- Participants in the ketamine study
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Revital Amiaz
Ramat Gan, RI, 52621
Revital Amiaz, MD, 0542378757, amiazr@gmail.com
Bat Chen Shlomy, +97235303350, revital.amiaz@sheba.health.gov.il
About this study
Official title: 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.
Read the 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.
- Conditions
- Followin Ketamine Treatment
- Keywords
- Major Depressive Disorder, ketamine, follow up, relapse
- Medical subject headings
- Depressive Disorder, Major, Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Medications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start14 Dec 2019
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Followin Ketamine TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The Chaim Sheba Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Revital Amiaz, The Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238039
- Sponsor's protocol ID
- 5826-18-SMC
- Acronym
- ket_Fol_Up
- Status last verified
- Jan 2020
- First submitted
- 18 Jan 2020
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Years Follow up: Add on Intravenous Ketamine for Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT04238039
- Acronym / sponsor ID
- ket_Fol_Up / 5826-18-SMC
- Conditions
- Followin Ketamine Treatment
- Keywords
- Major Depressive Disorder, ketamine, follow up, relapse
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- The Chaim Sheba Medical CenterUniversity, hospital or other
- Study start
- 14 Dec 2019 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in the ketamine study
Key inclusion criteria (1 listed)
- Participants in the ketamine study
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to relapse
Time frame: 5 years
Medications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Followin Ketamine Treatment, run by The Chaim Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.