AzTrials
AzTrials

Depressive Disorder, MajorPhase 2ISORADARNCT04171193

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

A Phase 2 study testing Isoflurane and Sertraline Pill in people with Depressive Disorder, Major and Treatment Resistant Depression, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Isoflurane and Sertraline Pill
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBrazil
Study dates
Dec 2019to Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Tiago Gil, MD contact

5511983817707

Tiagogil@gmail.colm

Brazil1 site

  • Insitute of Psychiatry of the University of São Paulo

    São Paulo

Other trials in Brazil

About this study

Official title: Efficacy of Deep Anaesthesia With Isoflurane as a Fast-response Antidepressant Agent in Treatment Resistant Depression Patients : Proof of Concept

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.

Read the detailed description

This study protocol will measure the efficacy of deep anesthesia, until burst suppression rate of 80% or more measured with Bi-spectral Index (BIS), with the volatile anesthetic Isoflurane. The investigators will select 30 subjects. The participants will be separated into 2 arms of 15 individuals. One arm called ISOAD will keep the oral treatment with antidepressants. The second arm, called ISO, will do a washout of any oral medications for depression. Both groups will go under six sessions, once per week, of deep anesthesia and will be followed up for 6 months to evaluate the survival of the antidepressant effect, if any effect happens. Before the anesthesia occurs, blood samples will be drawn to measure Brain-derived neurotrophic factor and investigators will apply depression rating scales such as MADRS and Hamilton - 17 , Young mania Scale, UKU scale for side effects, electroencephalogram will be recorder to be compared with the data shown on BIS. All the anesthesia procedure will be done with induction with propofol, fentanyl and muscular relaxant, to facilitate the tracheal intubation and compliance with the mechanical ventilator,based on body weight in standard dosages. Isoflurane will be set to 2,4% ( 2 cam) until Burst suppression rate >80% is achieve. Then the anesthesia will be maintained for 15 minutes, then the flow of anesthetic gas will be ended and the patient will be allowed to awake and discharged home when the anesthesiologist decide based on Aldrete Kroulik scale. After the 6th session the participant will return in one week to final evaluation. All the patients that shows improvement in depression scores will enter the phase 2 with one visit every 15 days for 2 months and then once a month until the 6th month. The non responders of the ISO group will start oral antidepressant sertraline to evaluate any potentialization effect of the intervention and be allocated in ISOPOT group. Those from ISOAD group (Isoflurane plus oral antidepressants) that did not respond to the intervention will be discontinued from the study and their data used in the study as non-responders. Those from ISOPOT group that did not improve their depression scores after 4 weeks will be discontinued from the study and the data computed as non-responders.

Being tested
Isoflurane, Sertraline Pill
Keywords
Isoflurane, Anesthesia, Treatment resistant depression, Deep anesthesia, Burst suppression, Depressive episode
Medical subject headings
Depressive Disorder, Major, Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IsofluraneDrug

    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

  • Sertraline PillDrug

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

Study groups in NCT04171193
Study groupRoleWhat they receive
ISOExperimentalPatients 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.
Receives: Drug: Isoflurane
ISOADExperimentalPatients 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
Receives: Drug: Isoflurane
ISOPOTExperimentalPatients 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.
Receives: Drug: Sertraline Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Depression severity - MADRS

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

    Measured: Six days after the last session

  2. Reduction in Depression - HDRS 17

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

    Measured: Six days after the last session

Secondary outcomes (9)

  1. Udvalg for Kliniske Undersøgelser - side effects rating scale

    Development and tolerability of collateral effects using the Udvalg for Kliniske Undersøgelser - side effects rating scale ( 0 to 43 - lower score means less side effects)

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

  2. Change in Depression severity MADRS

    Any change in Montgomery Asperger depression ratings scale ( 0 to 60 , lower score means less depression severity)

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

  3. Change in Depression severity HDRS17

    Any change in Hamilton depression ratings scale 17 ( 0 to 49, lower score means less depression severity)

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

  4. Magnitude MADRS

    The amount of the reduction, if any, in Montgomery Asperger Depression Rating Scale ( 0 to 60 , lower score means less depression severity)

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

  5. Magnitude HDRS 17

    The amount of the reduction, if any, in Hamilton Depression rating scale 17 ( 0 to 49, lower score means less depression severity)

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

  6. Survival of the effect - HDRS 17

    For how long the Hamilton Depression rating scale 17 remains below the initial value (lower value means less depression) in each participant that had variation in this scale

    Measured: After the 6th session through 24th week

  7. Survival of the effect - MADRS

    For how long the Montgomery Asperger Depression Rating Scale remains below the initial value (lower value means less depression) in each participant that had variation in this scale

    Measured: After the 6th session through 24th week

  8. Enhance HDRS 17

    The magnitude, if any, of the change in Hamilton Depression rating scale 17 measured in patients that did not achieve any primary outcome in the first phase of the study after started sertraline as oral antidepressant.

    Measured: After the 10th visit through the 24th week

  9. Enhance MADRS

    The magnitude, if any, of the change in Montgomery Asperger Depression Rating Scale measured in patients that did not achieve any primary outcome in the first phase of the study after started sertraline as oral antidepressant.

    Measured: After the 10th visit through the 24th week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2019
  2. Study startDec 2019 (estimated)
  3. Primary completionSep 2020 (estimated)
  4. Study completionDec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04171193
Sponsor's protocol ID
ISORADAR
Other IDs
19921719.9.0000.0068
Acronym
ISORADAR
Status last verified
Nov 2019
First submitted
6 Nov 2019
Last updated
20 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Isoflurane and Sertraline Pill in people with Depressive Disorder, Major and Treatment Resistant Depression, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tiago Gil, MD (5511983817707, Tiagogil@gmail.colm), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Depression severity - MADRS (time frame: Six days after the last session). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04171193.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in