Dexmedetomidine Adjuvant Treatment for Depressed Patients Undergoing ECT

NCT04661475 | Unknown Phase 4

• 1 other identifier: 13/2020
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

Major depressive disorder (MDD) is a highly prevalent and disabling condition for which the currently available treatments are not fully effective. Existing unmet needs include rapid onset of action and optimal management of concurrent agitation. Preliminary data support Dexmedetomidine as an antidepressant with fast onset of action, which would be especially helpful for patients experiencing treatment resistant depression, and agitation This trial will recruit 76 participants from the ECT waiting list at department of psychiatry and randomize them to either Dexmedetomidine infusion (0.5µg/kg/hr for 15 mins ) adjunct to ECT or Placebo adjunct to ECT( Saline) treatment arm added to standard anesthetic induction in depressed patients who have been prescribed ECT utilizing fixed randomization schedule that allocate subjects in to a 1:1 ratio between two arms.. Participants will receive ECT as described in the study schedule and as decided by their treating physician. Throughout the study, clinical, neuroimaging, molecular, and cognitive assessments will be conducted. The trial aims to show that compared with Placebo adjunct to ECT( Saline) treatment, Dexmedetomidine infusion adjunctive treatment will lead to higher and faster response rate in depression, lesser number of ECT sessions required to achieve antidepressant response, less incidence of confusion post ECT and comparable incidence of side effects . This could lead to faster, more effective treatment for patient with depression

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale

  Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline. * Response: \>50% reduction in MADRS from baseline and a score \<22 * Remission: MADRS ≤ 10

  1-3 WEEKS

Study Arms (2)

Dexmedetomidine adjunctive to ECT arm

EXPERIMENTAL

Drug: Dexmedetomidine Injection [Precedex]

Normal Saline adjunctive to ECT arm

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Dexmedetomidine Injection [Precedex] DRUG

ECT and anaesthetic treatment protocols will be determined by the local ECT services. ECT being given twice a week. The anesthetic induction agent of choice will usually be propofol, with thiopental permissible as an alternative. For safety reasons, any drug contraindicated to be given with DEX will be avoided. Especially the once known to decrease arterial pressure and heart rate excessively. Oral psychotropic medication to be continued by the patient's treating clinical team will remain unchanged where possible for at least the first 4 ECT treatments, and ideally until end of ECT. Eligible subjects will be allocated randomly to receive either 0.5µg/kg dexmedetomidine add on (diluted to 10 ml with 0.9% saline) at a steady rate of 1 ml/min, for 10 min.Participants in the two groups will receive DEX or Saline adjunct thrice weekly for 3 weeks.

Dexmedetomidine adjunctive to ECT arm

Normal saline DRUG

while patients in the Control group will be infused with 10 ml of 0.9% saline at the same rate, over 10 minutes before anesthesia induction for ECT procedure.

Normal Saline adjunctive to ECT arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients aging 18-70 years, with a DSM-5 diagnosis of MDD who will be commenced on ECT treatment by their treating psychiatrist.
• American Society of Anesthesiologists' (ASA) Physical Status class of I-II.
• Verbal IQ equivalent to 85 or greater and sufficiently fluent in English to validly complete neuropsychological testing.
• Provision of written informed consent before initiation of any study-related procedures.
• Eligible participants who have consented to standard ECT treatment for their mood disorder and are willing to accept randomization to either DEX+ECT or Placebo+ECT
• Subjects meeting criteria for Major Depressive Disorder (MDD) according to the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) currently in a Major Depressive Episode (MDE) as confirmed by the MINI International Neuropsychiatric Interview (MINI).
• A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of ≥ 26 at screening and at randomization, with no more than 20% improvement between these two visits.
• Female subjects of childbearing potential must have a negative urine pregnancy test at enrolment (Visit 1) and be willing to use a reliable method of birth control (i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation) during the study.
• Be able to understand and comply with the requirements of the study, as judged by the investigator(s).

You may not qualify if:

• Prior or current substance abuse or dependence (except for caffeine or nicotine dependence) and/or recent history (last 12 months) of current alcohol abuse or dependence, as defined in DSM-5 criteria ("a problematic pattern of using alcohol or another substance that results in impairment in daily life or noticeable distress").
• A positive toxicology screen for drugs that are not prescribed and Alcohol Use Disorder
• Vascular Depression due to stroke, or MDD in the context of cancer diagnoses or other severe medical illnesses( SLE, MS etc)
• Unwilling to maintain current antidepressant regimen.
• Unwilling to discontinue any narcotic for a minimum of 5 drug half-lives prior to DEX infusion
• Pregnant, lactating, or of childbearing potential and not willing to use an approved method of contraception during the study.
• Evidence of clinically relevant disease, e.g., uncontrolled hypertension, hypotension, renal or hepatic impairment, significant coronary artery disease (myocardial infarct within a year prior to initial randomization), cerebrovascular disease, cardiac insufficiency, sick sinus syndrome, bradycardia, atrioventricular block of degree II and III, history of cerebrovascular accident, viral hepatitis B or C, acquired immunodeficiency syndrome.
• A clinical finding that is unstable or that, in the opinion of the investigator(s), would be negatively affected by the study medication or that would affect the study medication (e.g., diabetes mellitus, hypertension, unstable angina).
• Liver function tests AST and ALT three times the upper normal limit at screening.
• Uncorrected hypothyroidism or hyperthyroidism. Subjects needing a thyroid hormone supplement to treat hypothyroidism must have been on a stable dose of the medication for 30 days prior to enrolment (Visit 1).
• Clinically significant deviation from the reference range in clinical laboratory test results( of liver , renal , thyroid, complete blood count ) as judged by the investigator(s).
• ECG results considered clinically significant as determined by the investigator(s), or outside of normal range as per cardiologist analysis.
• History of seizure disorder, except febrile convulsions.
• Known history of intolerance or hypersensitivity to DEX.
• Any other condition that, in the opinion of the investigator(s), would adversely affect the subject's ability to complete the study or its measure.

Sponsors & Collaborators

• Sultan Qaboos University: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Mohammed Salim A Alawi, MD

CONTACT

+14379725277; alalawim@squ.edu.om

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: .A double blind, placebo controlled, randomized Feasibility Study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Dr Mohmmed Al Alawi Bsc, MD, MRCPsych, OMSBPsych, ARABPsych

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: June 1, 2021
• Primary Completion: December 30, 2022
• Study Completion: March 2, 2023
• Last Updated: December 11, 2020

Record last verified: 2020-12