Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent

NCT04171193 | Unknown Phase 2

• 2 other identifiers: ISORADAR19921719.9.0000.0068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the investigators will submit patients with treatment resistant depression to deep anesthesia with isoflurane to get 15 minutes of cortical burst suppression on electroencephalogram, once a week for six weeks. The follow up will be for 6 months. The aim is to evaluate the change in depression severity during the entire period.

Conditions

Depressive Disorder, Major; Treatment Resistant Depression; Depressive Episode

Keywords

Isoflurane; Anesthesia; Treatment resistant depression; Deep anesthesia; Burst suppression; Depressive episode

Outcome Measures

Primary Outcomes (2)

• Reduction in Depression severity - MADRS

  Any reduction in Montgomery Asperger Depression Rating Scale ( 0 to 60 , lower score means less depression severity)

  Six days after the last session

• Reduction in Depression - HDRS 17

  Any reduction in Hamilton Depression rating scale 17 ( 0 to 49, lower score means less depression severity

  Six days after the last session

Secondary Outcomes (9)

• Udvalg for Kliniske Undersøgelser - side effects rating scale

  From 6th day after the first intervention up to week 24th

• Change in Depression severity MADRS

  From 6th day after the intervention up to week 24th

• Change in Depression severity HDRS17

  From 6th day after the intervention up to week 24th

• Magnitude MADRS

  From 6th day after the intervention up to week 24th

• Magnitude HDRS 17

  From 6th day after the intervention up to week 24th

Study Arms (3)

ISO

EXPERIMENTAL

Patients not taking oral medications for depression. They will receive the study intervention consisting in general anesthesia with the volatile anesthetic gas Isoflurane until burst suppression is detected in electroencephalogram more than 80% of the time for 15 minutes.

Drug: Isoflurane

ISOAD

EXPERIMENTAL

Patients in treatment with oral medications for depression, will receive intervention consisting in general anesthesia with the volatile anesthetic gas Isoflurane until burst suppression is detected in electroencephalogram more than 80% of the time for 15 minutes

Drug: Isoflurane

ISOPOT

EXPERIMENTAL

Patients that where from ISO arm, that did not respond to intervention consisting in general anesthesia with the volatile anesthetic gas Isoflurane until burst suppression is detected in electroencephalogram more than 80% of the time for 15 minutes They will now, start taking sertraline as oral medication for depression to asset the enhancement of oral treatment after Isoflurane challenge.

Drug: Sertraline Pill

Interventions

Isoflurane DRUG

Deep anesthesia with isoflurane to achieve burst suppression pattern for more than 80% of the time for 15 minutes measured in electroencephalogram and Bi-Spectral Index

ISO; ISOAD

Sertraline Pill DRUG

Patients that did not respond to Isoflurane treatment, will star on sertraline to evaluate any enhancement in antidepressant efficacy after pre-treatment with isoflurane

ISOPOT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Treatment resistant depression on depressive state with or without psychiatric comorbidities for anxious features
• moderate to severe condition measured by Montgomery Asperger Depression Rating Scale and Hamilton Depression rating scale - 17
• be between 18 and 60 years old
• IF female, do not be pregnant and use a trustable contraceptive method
• can read and write in Portuguese language
• will to be in all the phases of the study
• have agreed with free will to participate
• classified as American Society of Anesthesiologists - Physical Status 1 or 2 by a certified anesthesiologist
• Suicide ideation measured by Montgomery Asperger Depression Rating Scale on item 10 less than 4

You may not qualify if:

• drug abusers in the last 6 months, except for nicotine
• use of benzodiazepines or lamotrigine less then 15 days from the first session
• family history of malignant hyperthermia Suicidal ideation on item 10 of Montgomery Asperger Depression Rating Scale more than 4
• Suicide attempt one month prior the study begins

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Insitute of Psychiatry of the University of São Paulo

São Paulo, Brazil

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Interventions

Isoflurane; Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; 1-Naphthylamine; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Ricardo Alberto Moreno, Phd

  Instituto de Psiquiatria do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

  STUDY DIRECTOR

Central Study Contacts

Tiago Gil, MD

CONTACT

5511983817707; Tiagogil@gmail.colm

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR: MOOD DISORDERS UNIT (GRUDA)

Model Details: We will have two groups, one arm with oral antidepressants and other arm without oral antidepressants, no placebo, no control. Everyone receives the intervention. Those who respond to treatment, will be followed for 24 weeks, those who do not respond, if not in the oral antidepressant group, will star oral antidepressants and be followed for 24 weeks

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 20, 2019
• Study Start: December 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

BR (1)