Study to Assess the Effects of Intranasal Ketamine Along With rTMS for Patients With Treatment-resistant Major Depressive Disorder (TRD)

NCT04352621 | Unknown Phase 4 DMC FDA Drug

• 1 other identifier: Nelson Ketamine IIT
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Major Depressive Disorder

Keywords

treatment-resistant major depressive

Outcome Measures

Primary Outcomes (1)

• 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.

  Screening to through study completion, an average of 42 days

Study Arms (1)

Ketamine plus rTMS

EXPERIMENTAL

Patients will be given a dose of ketamine followed by 6 weeks of rTMS treatment.

Drug: intranasal ketamine; Device: rTMS treatment

Interventions

intranasal ketamine DRUG

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. .

Also known as: Ketamine

Ketamine plus rTMS

rTMS treatment DEVICE

patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit).

Also known as: Repetitive transcranial magnetic stimulation (rTMS)

Ketamine plus rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Ketamine; Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Magnetic Field Therapy; Therapeutics

Central Study Contacts

Jade Lord

CONTACT

513-558-4997; lordje@ucmail.uc.edu

Erik Nelson, MD

CONTACT

513-558-5115; nelsoneb@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 16, 2020
• First Posted: April 20, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share