Major DepressionPhase 2NCT01135758
Study of Depression-Ketamine-Brain Function
A Phase 2 study testing Ketamine in people with Major Depression, run by Markus KOSEL at 1 site in Switzerland.
Trial summary
Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.Ketamine has been proposed as a novel approach to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2010to Sep 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features.
- Drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose)
- Score 25 or higher on the Montgomery-Asberg Depression Rating Scale
- Stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion.
- Legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an MRI examination.
Who cannot join
- Subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption.
- Patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the MADRS).
- Patients with any other DSM-IV axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation.
- History of antidepressant or substance-induced hypomania or mania.
- History of psychotic symptoms.
- Patients with any contra-indication to the administration of ketamine, especially present diagnosis or antecedents of clinically relevant cardiovascular disorders (clinically significant or not adequately treated hypertension, present or previous diagnosis of cardiovascular disorder such as stroke or heart attack etc).
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- Any MRI contraindication, especially metallic implants, pacemaker, etc.
- Pregnant women, breast-feeding women, women of childbearing age without effective means of contraception.
- Treatment during the last 2 weeks with thyroid hormones and sympathicomimetic drug.
- Present or past diagnosis of eclampsia or preeclampsia.
- Untreated or insufficiently treated hyperthyroidism.
- Known hypersensitivity to ketamine or to the excipient (benzethonium chloride).
- Present or past diagnosis of glaucoma, intracranial hypertension.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Psychiatrie Adulte, Programme dépression
Geneva, 1207
About this study
Official title: Pilot Study Probing the Antidepressant Effects of 0.5 mg/kg Intravenous Ketamine in Drug-resistant Depressed Patients (Unipolar Depression): Efficacy, Safety, Brain Function
Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.Ketamine has been proposed as a novel approach to induce rapid antidepressant response. In this pilot project the investigators aim to introduce this novel and promising approach into clinical practice. Besides the assessment of clinical efficacy, the investigators will put a special emphasis on the assessment of ketamine-associated effects on brain function using fMRI and cognitive testing.
- Conditions
- Major Depression
- Being tested
- Ketamine
- Keywords
- depression, ketamine, fMRI
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| ketamine 0.5 mg/kg i.v. | Experimental | Single administration of ketamine 0.5 mg/kg i.v. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the MADRS score at baseline and after ketamine injection
Measured: 40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2015
- Study completionSep 2015
Why it stopped: End of funding of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus KOSEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Markus KOSEL, University Hospital, Geneva
- Investigators
- Markus Kosel, MD-PhD, Principal investigator, Departement of Adult Psychiatry, University Hospital of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135758
- Sponsor's protocol ID
- CE09-144/Psy 09-22
- Status last verified
- Dec 2015
- First submitted
- 2 Jun 2010
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Probing the Antidepressant Effects of 0.5 mg/kg Intravenous Ketamine in Drug-resistant Depressed Patients (Unipolar Depression): Efficacy, Safety, Brain Function
- ClinicalTrials.gov ID
- NCT01135758
- Acronym / sponsor ID
- CE09-144/Psy 09-22
- Conditions
- Major Depression
- Keywords
- depression, ketamine, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of funding of study
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Markus KOSELUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jun 2010 (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.
Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.Ketamine has been proposed as a novel approach to induce rapid antidepressant response. In this pilot project the investigators aim to introduce this novel and promising approach into clinical practice. Besides the assessment of clinical efficacy, the investigators will put a special emphasis on the assessment of ketamine-associated effects on brain function using fMRI and cognitive testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ketamine 0.5 mg/kg i.v. | Experimental | Drug: KetamineSingle administration of ketamine 0.5 mg/kg i.v. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features.
- Drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose)
- Score 25 or higher on the Montgomery-Asberg Depression Rating Scale
- Stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion.
- Legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an MRI examination.
Key exclusion criteria (13 listed)
- Subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption.
- Patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the MADRS).
- Patients with any other DSM-IV axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation.
- History of antidepressant or substance-induced hypomania or mania.
- History of psychotic symptoms.
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 |
|---|---|---|
| KetamineAdministration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg) | Drug | ketamine 0.5 mg/kg i.v. |
Primary outcome
Difference of the MADRS score at baseline and after ketamine injection
Time frame: 40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration
Results and safety
The study was stopped early (reason given: End of funding of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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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.
Markus Kosel, MD-PhD principal investigator
Departement of Adult Psychiatry, University Hospital of Geneva
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 in people with Major Depression, run by Markus KOSEL at 1 site in Switzerland.
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 5 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: stopped early, as of the sponsor's last update on 7 Dec 2015. 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 Switzerland. 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?
The study was stopped early (reason given: End of funding of study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the MADRS score at baseline and after ketamine injection (time frame: 40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration). 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 7 Dec 2015.