Major Depressive DisorderPhase 4NCT04352621
Study to Assess the Effects of Intranasal Ketamine Along With rTMS for Patients With Treatment-resistant Major Depressive Disorder (TRD)
A Phase 4 study testing intranasal ketamine and rTMS treatment in people with Major Depressive Disorder, run by University of Cincinnati.
Trial summary
An open label study to assess the safety, tolerability, and effects of intranasal Ketamine in combination with rTMS for patients with treatment-resistant major depressive disorder (TRD). Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- intranasal ketamine and rTMS treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 May 2022
- Phase
- Phase 4
- 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
- Males and non-pregnant females currently meeting the DSM-5 criteria for diagnosis of major depressive disorder (MDD), single episode or recurrent, with a current episode duration of 3 years or less (confirmed with the MINI);
- episode has a Clinical Global Impressions Severity of Illness (CGI-S) score of at least 4 and a total score of at least 20 on the 17-item Hamilton Depression Rating Scale (HAMD17)
- Age between 18-65
- HAMD17 total score of at least 20 and a decrease in score of 25% or less from that observed at the screening assessment
- Willing and able to provide informed consent
- History of failure to respond (<25% improvement) to at least one, but not more than four antidepressant trial in the current episode. Alternatively, patients will be eligible if they have marked intolerance to antidepressants as demonstrated by four failed attempts to tolerate an adequate medication trial (lifetime).
Who cannot join
- Unable to speak English well enough to participate in the rating scales which will only be provided in English.
- Pregnancy or lactation
- Post-partum state (within 2 months of delivery);
- History of substance abuse or dependence within the past year (except nicotine and caffeine)
- a lifetime history of psychosis, bipolar disorder, or obsessive- compulsive disorder;
- diagnosis of posttraumatic stress disorder or an eating disorder in the past year
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- lack of response to a past adequate trial of electroconvulsive therapy (ECT) for MDD;
- prior treatment with TMS or a vagus nerve stimulator implant;
- use of hallucinogen in the last month
- Current treatment with any medication NMDA receptor effects
- Any history of prior ketamine use
- Any clinically-significant medication or condition that would preclude the use of ketamine.
- History of: a dissociative disorder, seasonal patteren of depression as defined by DSM-IV, any condition likely to be associated with increased intracranial pressure, space occyping lesion, seizure disorder except childhood febrile seizures, neurologic disorder or medication therapy known to alter seizure threshold, cerebrovascular accident, transient ischemic attack within the last 2 years, cerebral aneurysm, dementia, parkinson's disease, hunging's disease, multiple sclerosis, or a personality disorder (which in the judgement of the Investigator may hinder the patient in completing the procedures required by the study protocol)
- Presence of ferromagnetic material in or in close proximity to the head.
- Increased risk of seizure for any other reason, including prior diagnosis of increased intracranial pressure, pseudotumor cerebri, or history of significant head trauma with loss of consciousness for greater than or equal to 5 minutes
- A true positive response to any question on the Transcranial Magnetic Stimulation Adult Safety Screen questionnaire
- Inability to locate and quantify a motor threshold as defined in the protocol
- ECT treatment within 3 months prior to the screening visit
- Use of any investigational drug within 4 weeks of the baseline visit
- Use of fluoxetine within 6 weeks of the baseline visit
- Use of an MAOI within 2 weeks of the baseline visit
- Use of any antidepressant within 1 week of the baseline visit
- Significant acute suicide risk, defined as follows: Suicide attempt within the previous 6 months that required medical treatment; or Greater than or equal to 2 suicide attempts in the past 12 months; or
- Has a clear-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the Investigator if the impulse to implement the plan becomes substantial during the study; or In the investigator's opinion, is likely to attempt suicide within the next 6 months.
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease;
- If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial
- Positive urine drug screen. (A positive urine drug screen at screening may be repeated once prior to randomization)
- Clinically significant laboratory abnormality on CBC, TSH, ECG or hepatic profile in the opinion of the Investigator
- Any known hypersensitivity or serious adverse effect with ketamine
- Any clinically-significant medication or condition that would preclude the use of ketamine including respiratory illness requiring the regular use of oxygen.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ketamine Enhancement of rTMS for Refractory Depression
An open label study to assess the safety, tolerability, and effects of intranasal Ketamine in combination with rTMS for patients with treatment-resistant major depressive disorder (TRD). Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment.
Read the detailed description
Investigate the effects of pretreatment using a single, sub-anesthetic dose of intranasal ketamine on the response to a standard course of rTMS in patients who meet the definition of TRD.
- Conditions
- Major Depressive Disorder
- Being tested
- intranasal ketamine, rTMS treatment
- Keywords
- treatment-resistant major depressive
- 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.
intranasal ketamineDrug
Also called Ketamine
Ketamine 0.5 mg/kg will be administered intranasally using an atomization device with a maximum dose of 40 mg followed by 6 weeks of rTMS treatment. .
rTMS treatmentDevice
Also called Repetitive transcranial magnetic stimulation (rTMS)
patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit).
| Study group | Role | What they receive |
|---|---|---|
| Ketamine plus rTMS | Experimental | Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment. Receives: Drug: intranasal ketamine; Device: rTMS treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inventory for Depressive Symptomatology - Self-Rated
To assess the effects of 0.5 mg/kg intranasal ketamine on response to rTMS treatment as measured by the Inventory for Depressive Symptomatology, Self-Rated Version (IDS-SR) in patients with strictly defined treatment resistant depression.
Measured: Screening to through study completion, an average of 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To assess the effects of 0.5 mg/kg intranasal ketamine on response to rTMS treatment as measured by the Inventory for Depressive Symptomatology, Self-Rated Version (IDS-SR) in patients with treatment resistant depression (\< 25% response to between 1 and 4 adequate antidepressant trials in the current episode).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Nelson, MD, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352621
- Sponsor's protocol ID
- Nelson Ketamine IIT
- Status last verified
- Apr 2020
- First submitted
- 16 Feb 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Enhancement of rTMS for Refractory Depression
- ClinicalTrials.gov ID
- NCT04352621
- Acronym / sponsor ID
- Nelson Ketamine IIT
- Conditions
- Major Depressive Disorder
- Keywords
- treatment-resistant major depressive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 20 Apr 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.
An open label study to assess the safety, tolerability, and effects of intranasal Ketamine in combination with rTMS for patients with treatment-resistant major depressive disorder (TRD). Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment.
Detailed description
Investigate the effects of pretreatment using a single, sub-anesthetic dose of intranasal ketamine on the response to a standard course of rTMS in patients who meet the definition of TRD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To assess the effects of 0.5 mg/kg intranasal ketamine on response to rTMS treatment as measured by the Inventory for Depressive Symptomatology, Self-Rated Version (IDS-SR) in patients with treatment resistant depression (< 25% response to between 1 and 4 adequate antidepressant trials in the current episode).
| Arm | Type | Receives |
|---|---|---|
| Ketamine plus rTMS | Experimental | Drug: intranasal ketamine, Device: rTMS treatmentPatients will be given a dose of ketamine followed by 6 weeks of rTMS treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-pregnant females currently meeting the DSM-5 criteria for diagnosis of major depressive disorder (MDD), single episode or recurrent, with a current episode duration of 3 years or less (confirmed with the MINI);
- episode has a Clinical Global Impressions Severity of Illness (CGI-S) score of at least 4 and a total score of at least 20 on the 17-item Hamilton Depression Rating Scale (HAMD17)
- Age between 18-65
- HAMD17 total score of at least 20 and a decrease in score of 25% or less from that observed at the screening assessment
- Willing and able to provide informed consent
Key exclusion criteria (30 listed)
- Unable to speak English well enough to participate in the rating scales which will only be provided in English.
- Pregnancy or lactation
- Post-partum state (within 2 months of delivery);
- History of substance abuse or dependence within the past year (except nicotine and caffeine)
- a lifetime history of psychosis, bipolar disorder, or obsessive- compulsive disorder;
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 |
|---|---|---|
| intranasal ketamineAlso: KetamineKetamine 0.5 mg/kg will be administered intranasally using an atomization device with a maximum dose of 40 mg followed by 6 weeks of rTMS treatment. . | Drug | Ketamine plus rTMS |
| rTMS treatmentAlso: Repetitive transcranial magnetic stimulation (rTMS)patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit). | Device | Ketamine plus rTMS |
Primary outcome
Inventory for Depressive Symptomatology - Self-Rated
Time frame: Screening to through study completion, an average of 42 days
To assess the effects of 0.5 mg/kg intranasal ketamine on response to rTMS treatment as measured by the Inventory for Depressive Symptomatology, Self-Rated Version (IDS-SR) in patients with strictly defined treatment resistant depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intranasal ketamine and rTMS treatment in people with Major Depressive Disorder, run by University of Cincinnati.
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 6 inclusion and 30 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 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Jade Lord (513-558-4997, lordje@ucmail.uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inventory for Depressive Symptomatology - Self-Rated (time frame: Screening to through study completion, an average of 42 days). 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 20 Apr 2020.