- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352621
Study to Assess the Effects of Intranasal Ketamine Along With rTMS for Patients With Treatment-resistant Major Depressive Disorder (TRD)
April 17, 2020 updated by: Erik Nelson, MD, University of Cincinnati
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.
Study Overview
Status
Unknown
Conditions
Intervention / 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 Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jade Lord
- Phone Number: 513-558-4997
- Email: lordje@ucmail.uc.edu
Study Contact Backup
- Name: Erik Nelson, MD
- Phone Number: 513-558-5115
- Email: nelsoneb@ucmail.uc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketamine plus rTMS
Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment.
|
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. .
Other Names:
patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Screening to through study completion, an average of 42 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2020
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
May 1, 2022
Study Registration Dates
First Submitted
February 16, 2020
First Submitted That Met QC Criteria
April 17, 2020
First Posted (Actual)
April 20, 2020
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 17, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- Nelson Ketamine IIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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