Major Depressive EpisodePhase 2NCT02992496
Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
A Phase 2 study testing Ketamine and Midazolam Hydrochloride in people with Major Depressive Episode, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Ketamine and Midazolam Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 24 Apr 2017to Dec 2020
- Phase
- Phase 2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
- Hamilton depression rating scale score ≥ 19
- Willingness and competence to sign the informed consent form
- Stable psychopharmacological treatment for 10 days (except benzodiazepines)
Who cannot join
- Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
- Prior use of ketamine
- Pregnancy/Breast feeding
- Instable arterial hypertension >170/110mmHg
- Hepatic dysfunction
- Hyperthyreosis
Show all 13Show fewer
- History of glaucoma
- Neurodegenerative disorders
- Any unstable medical illness
- History of substance abuse within the past 12 months
- History of psychosis
- Failure to comply with the study protocol or to follow the instructions of the investigating team
- Current treatment with one of the following drugs: clopidogrel, carbamazepine, valproate, barbiturates, memantine, modafinil, disulfiram, amiodarone, ranolazine, phenytoin, verapamil, fibrates, antiretroviral agents, antimicrobial chemotherapeutics, azole antifungals, glucocorticoids, cyclosporine, valeriana/garlic/grapefruit preparations, St. John's wort.
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, 1090
Rupert Lanzenberger, A/Prof., +43 40400 ext. 35760, rupert.lanzenberger@meduniwien.ac.at
Rupert Lanzenberger, A/Prof. MD
About this study
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
- Conditions
- Major Depressive Episode
- Being tested
- Ketamine, Midazolam Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
1mg/kg, 6 applications over 2 weeks
Midazolam HydrochlorideDrug
0.03mg/kg, 6 applications over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ketamine treatment group | Active comparator | Each patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks. Receives: Drug: Ketamine |
| Control group | Active comparator | Each patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks Receives: Drug: Midazolam Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured: 1 week
Secondary outcomes (2)
Clinician Administered Dissociative States Scale (CADSS)
Measured: 2 weeks
Hamilton Depression Rating Scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start24 Apr 2017
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992496
- Sponsor's protocol ID
- v1.2_20161024
- Status last verified
- Aug 2019
- First submitted
- 12 Dec 2016
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Antidepressant Efficacy of Oral Ketamine Treatment
- ClinicalTrials.gov ID
- NCT02992496
- Acronym / sponsor ID
- v1.2_20161024
- Conditions
- Major Depressive Episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 14 Dec 2016 (estimated)
- 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.
The purpose of this double-blind, controlled, randomized study is to investigate the antidepressant efficacy of oral ketamine treatment in patients suffering from a major depressive episode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine treatment group | Active comparator | Drug: KetamineEach patient will undergo six treatment sessions with 1mg/kg oral ketamine over 2 weeks. |
| Control group | Active comparator | Drug: Midazolam HydrochlorideEach patient will undergo six treatment sessions with 0.03mg/kg oral midazolam over 2 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of a major depressive episode in the scope of a major depressive or bipolar disorder supported by a Structured Clinical Interview for DSM-IV-TR (SCID)
- Hamilton depression rating scale score ≥ 19
- Willingness and competence to sign the informed consent form
- Stable psychopharmacological treatment for 10 days (except benzodiazepines)
Key exclusion criteria (13 listed)
- Initiation of a new antidepressant or mood stabilizing treatment (pharmacological, physical or psychotherapeutic) with adequate dosage (as defined by the minimum recommended dose in the respective prescribing information) within 4 weeks prior to inclusion
- Prior use of ketamine
- Pregnancy/Breast feeding
- Instable arterial hypertension >170/110mmHg
- Hepatic dysfunction
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 |
|---|---|---|
| Ketamine1mg/kg, 6 applications over 2 weeks | Drug | Ketamine treatment group |
| Midazolam Hydrochloride0.03mg/kg, 6 applications over 2 weeks | Drug | Control group |
Primary outcome
Montgomery-Åsberg Depression Rating Scale (MADRS)
Time frame: 1 week
2 secondary outcomes
Clinician Administered Dissociative States Scale (CADSS)
Time frame: 2 weeks
Hamilton Depression Rating Scale
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Department of Psychiatry and Psychotherapy, Medical University of Vienna
Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine and Midazolam Hydrochloride in people with Major Depressive Episode, run by Medical University of Vienna at 1 site in Austria.
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 13 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 3 Sep 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 Austria. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Montgomery-Åsberg Depression Rating Scale (MADRS) (time frame: 1 week). 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 3 Sep 2019.