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Dexmedetomidine Adjuvant Treatment for Depressed Patients Undergoing ECT

NCT04661475 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2020-12-11

No results posted yet for this study

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

Interventions

DRUG

Dexmedetomidine Injection [Precedex]

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.

DRUG

Normal saline

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.

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-12-30
Completion
2023-03-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04661475 on ClinicalTrials.gov