Depressive Disorder, MajorNCT04021433
Ketamine for Treatment Resistant MDD
A study testing Ketamine in people with Depressive Disorder, Major, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2018to 30 Dec 2020
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with unipolar/bipolar depression with MADRS Score>= 20
- Inadequate response to >= 3 adequate treatment trials [>=2 trials in the present episode]
- If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
- QTc WNL
Who cannot join
- Hypersensitivity to ketamine
- Other major psychiatric diagnosis
- High suicidality
- Unstable physical illness
- S/P CVA / brain SOL
- Pregnant or breast feeding women
- Illicit drug/alcohol abuse during last year
- History of ketamine abuse
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Hebrew University Medical Center
Jerusalem
Isserles Moshe, MD, MSc
About this study
Official title: Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study
This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.
Read the detailed description
Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.
In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.
- Conditions
- Depressive Disorder, Major
- Being tested
- Ketamine
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Repeated doses of IM/SC ketamine up to 3 times a week
| Study group | Role | What they receive |
|---|---|---|
| MDD | Experimental | Treatment resistant patients will be treated with multiple doses of IM/SC ketamine [dose range 0.3-1.5mg/kg] Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline
Measured: 1 month into treatment through study completion
Secondary outcomes (4)
MADRS
The change in MADRS score at 3 months compared to baseline.
Measured: 3 months into treatment
QIDS-SR, Clinical Global Impressions - Improvement
The change in QIDS-SR and CGI scores at 1, 3 and 6 months compared to baseline.
Measured: along 6 months
Average time in remission
Average time in remission.
Measured: along 6 months
NeuroTrax computerized cognitive battery
Changes in cognitive function at 1 and 6 months [or at study end] as assessed by the NeuroTrax computerized cognitive battery compared to baseline.
correlation between information processing speed and other cognitive domains at baseline and clinical outcomes.
Measured: along 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start1 Sep 2018
- Primary completion1 Oct 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- open
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021433
- Sponsor's protocol ID
- 58717-HMO-CTIL
- Status last verified
- Jun 2019
- First submitted
- 10 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine for Treatment Resistant Depression - A Long Term Feasibility Study
- ClinicalTrials.gov ID
- NCT04021433
- Acronym / sponsor ID
- 58717-HMO-CTIL
- Conditions
- Depressive Disorder, Major
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 16 Jul 2019 (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.
This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IM/SC ketamine for treatment resistant MDD.
Detailed description
Major depression disorder (MDD) is a common psychiatric disorders with considerable impact on patients' quality of life, social and occupational function. MDD also significantly increase suicide rate. About a third of the patients with MDD suffer from moderate to severe symptoms that are fully or partially unresponsive to accepted pharmaco and / or psycho therapy. Ketamine is a widely used anesthetic. Multiple studies done over the recent years had shown its therapeutic effects in resistant depressive patients. Unlike regular antidepressants, ketamine exerts its effect within hours to few days which implies an alternative mechanism of action not fully studied. So far, there are only few reports on using repeated ketamine administration to maintain the antidepressant effect or on intra-muscular or sub-cutaneous application that can be safer and more tolerable than the intravenous route.
In the present study, the investigators aim to openly assess the safety, tolerability and effectiveness of repeated, individually tailored IM or SC ketamine for treatment resistant major depression. The investigators intend to explore questions regarding optimal dose, treatment frequency and duration. The investigators will also assess potential cognitive effects of long-term ketamine treatment and look for possible treatment outcome predictors using the Neurotrax computerized cognitive battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open
| Arm | Type | Receives |
|---|---|---|
| MDD | Experimental | Drug: KetamineTreatment resistant patients will be treated with multiple doses of IM/SC ketamine [dose range 0.3-1.5mg/kg] |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with unipolar/bipolar depression with MADRS Score>= 20
- Inadequate response to >= 3 adequate treatment trials [>=2 trials in the present episode]
- If on psychopharmacological Tx, it should be stable since 4 weeks prior to enrollment
- QTc WNL
Key exclusion criteria (8 listed)
- Hypersensitivity to ketamine
- Other major psychiatric diagnosis
- High suicidality
- Unstable physical illness
- S/P CVA / brain SOL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineRepeated doses of IM/SC ketamine up to 3 times a week | Drug | MDD |
Primary outcome
MADRS
Time frame: 1 month into treatment through study completion
The change in the MDRS score at 1 month (5weeks evaluation) for the acute phase and at 6 months or end of study (for the maintenance phase) compared to baseline
4 secondary outcomes
MADRS
Time frame: 3 months into treatment
QIDS-SR, Clinical Global Impressions - Improvement
Time frame: along 6 months
Average time in remission
Time frame: along 6 months
NeuroTrax computerized cognitive battery
Time frame: along 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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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?
A study testing Ketamine in people with Depressive Disorder, Major, run by Hadassah Medical Organization 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 4 inclusion and 8 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 16 Jul 2019. 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?
Contact Moshe Isserles, MD (00972 2 6777184, moshay@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: 1 month into treatment through study completion). 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 16 Jul 2019; AzTrials last refreshed its copy on 30 Oct 2026.