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Major Depressive DisorderPhase 4NCT04181567

Comparison of the Efficacy, Safety, and Relapse of ECT to ECT Plus Agomelatine for Depressed Patients

A Phase 4 study testing electroconvulsive therapy and agomelatine in people with Major Depressive Disorder, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our hypothesis is that using antidepressants during the ECT has a better efficacy and longer time to relapse/recurrence to the ECT without antidepressants. The purpose of this study is to compare the efficacy, safety, and time to relapse/recurrence of ECT to ECT plus agomelatine in the treatment of patients with major… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
electroconvulsive therapy and agomelatine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
1 siteTaiwan
Study dates
3 Mar 2014to 22 Nov 2019
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Major depressive disorder
  • Aged 18 years or older
  • HAMD-17 >=18
  • CGI-S >=4
  • Treatment-resistant depression: a lack of response to two or more adequate trials of different classes of antidepressants
  • Given written informed consent

Who cannot join

  • History of schizophrenia, schizoaffective disorder or organic mental disorders
  • Severe cognitive impairment
  • Female subjects with lactation or pregnancy
  • Serious medical conditions or neurological illnesses that restricte the use of ECT
  • Receiving ECT within the 6 months
  • Substance abuse/dependence within the 6 months.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Municipal Kai-Syuan Psychiatric Hospital

    Kaohsiung City, 886

Other trials in Taiwan

About this study

Official title: A Randomized, Double-blind, Comparison of the Efficacy, Safety, and Relapse of Electroconvulsive Therapy (ECT) to ECT Plus Agomelatine in the Treatment of Patients With Major Depressive Disorder

Our hypothesis is that using antidepressants during the ECT has a better efficacy and longer time to relapse/recurrence to the ECT without antidepressants. The purpose of this study is to compare the efficacy, safety, and time to relapse/recurrence of ECT to ECT plus agomelatine in the treatment of patients with major depressive disorder. Inpatients with major depressive disorder for ECT will be randomly assigned to double-blind treatment with placebo or agomelatine 50 mg/d.

Read the detailed description

Objective: Electroconvulsive therapy (ECT) is the safe and the most effective treatment for patients with major depressive disorder. It is still inconclusive whether antidepressants are continued during the course ot ECT. In terms of efficacy and safety, three essential questions arise: 1) does concomitant treatment improve the short-term antidepressant effects of ECT, 2) does concomitant treatment reduce the rate of early relapse/recurrence following ECT, 3) does concomitant treatment has more side effects? The purpose of this study is to conduct a clinical trial to compare the efficacy, safety, and time to relapse/recurrence of ECT to ECT plus agomelatine in the treatment of patients with major depressive disorder.

Methods: This is a prospective study. Inpatients with major depressive disorder for ECT will be randomly assigned to double-blind treatment with placebo or agomelatine 50 mg/d. After the ECT, the patients who meet the response criteria (i.e., at least a 50% reduction in symptom scores) or receive at least 6 treatments (i.e., acute phase) will receive the agomelatine 50 mg/d for 3 months (i.e., follow-up phase). The severity of depression, severity of anxiety, psychosocial functioning and side effects will be measured using the 17-item Hamilton Rating Scale for Depression (HAMD-17), the Clinical Global Impression-Severity (CGI-S), Depression and Somatic Symptoms Scale (DSSS), Zung's Depression Scale (ZDS), Hamilton Anxiety Rating Scale (HAM-A), Global Assessment of Functioning (GAF), Work and Social Adjustment Scale (WSAS), and UKU Side Effect Rating Scale before ECT, after every 3 sessions of ECT, at the end of acute ECT, and monthly during the 3-month follow-up period. Medical Outcomes Study Short-Form 36, Arizona Sexual Experiences Scale(ASEX), MINI Mental State Examination (MMSE), neuropsychological tests, and electroencephalography will be assessed before ECT, after ECT, and after the 3-month follow-up period. Questionnaire for patient attitudes about ECT after acute ECT will be completed. The Pearson chi-square test will be used to compare the response rate and remission (i.e., HAM-17≦7) rate between two groups. Analyses of group differences in efficacy will be performed by generalized estimating equations or ANCOVA. Survival analysis will be used to compare the time to response/remission and time to relapse/recurrence (i.e., HAM-D-17≧14 or CGI-S ≧4 or rehospitalization) after ECT between two groups.

Expected results: The results will provide evidence base for clinicians to decide to use antidepressants during ECT or not.

Being tested
electroconvulsive therapy, agomelatine, Placebo
Keywords
electroconvulsive therapy, agomelatine, relapse, major depressive disorder, response
Medical subject headings
Depressive Disorder, Major, Recurrence

What participants receive

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

  • electroconvulsive therapyOther

    Also called ECT

    electroconvulsive therapy 2 times weekly

  • agomelatineDrug

    agomelatine

  • PlaceboDrug

    placebo

Study groups in NCT04181567
Study groupRoleWhat they receive
electroconvulsive therapy + agomelatineExperimentalelectroconvulsive therapy 2 times weekly + agomelatine 50 mg daily
Receives: Other: electroconvulsive therapy; Drug: agomelatine
electroconvulsive therapy + placeboActive comparatorelectroconvulsive therapy 2 times weekly + placebo
Receives: Other: electroconvulsive therapy; Drug: Placebo

What is being measured

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

  1. 17-item Hamilton Rating Scale for Depression (HAMD-17)

    The HAMD-17 is widely used in clinical setting to evaluate depression symptoms in the past week. Higher total HAMD-17 scores (ranging from 0 to 52) indicate more severe depression.

    Measured: up to month 3.

Secondary outcomes (9)

  1. Clinical severity by Clinical Global Impression-Severity (CGI-S)

    The CGI-S is developed for use in NIMH-sponsored clinical trials to provide a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises one-item measures evaluating the severity of psychopathology from 1 to 7 and higher scores indicate higher severity.

    Measured: In acute phase, the CGI-S is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the CGI-S is rated at months 1, 2, and 3.

  2. Work and Social Adjustment Scale (WSAS)

    The Work and Social Adjustment Scale (WSAS) is a 5-item self-rating scale designed to measure psychosocial functional impairment. Each item is scored from 0 (not affected at all) to 8 (severely affected).

    Measured: In acute phase, the WSAS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the WSAS is rated at months 1, 2, and 3.

  3. UKU side effects rating scale

    UKU side effects rating scale, with the score of each item ranging from 0 (none) to 3 (severe), is used to measure adverse events during the study period.

    Measured: In acute phase, the UKU scale is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the UKU scale is rated at months 1, 2, and 3.

  4. Electroencephalograph (EEG)

    The EEG is used to analyze the change of electroencephalogram complexity. EEG The recording lasted about 3 minutes after habituation to environment, and the EEG technician monitored subject vigilance. Recordings are in 19 electrodes (Fp1, Fp2, F7, F3, Fz, F4, F8, T7, C3, Cz, C4, T8, P7, P3, Pz, P4, P8, O1, O2) in the standard 10-20 International placement with mastoid reference. The raw EEG signal is transposed to MATLAB software (MathWorks Inc., Natick, MA, USA) for processing. Each electrode complexity will be calculated.

    Measured: In acute phase, the EEG is recorded at baseline and again at week 6 (or on early termination). In follow-up phase, the EEG is recorded at month 3.

  5. Medical Outcomes Study Short-Form 36 (SF-36)

    The SF-36 is used to assay the quality of life. Scores for the 8 SF-36 subscales range from 0 to 100, with a higher score representing better QOL.

    Measured: In acute phase, the SF-36 is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the SF-36 is rated at month 3.

  6. Mini Mental State Examination (MMSE)

    The MMSE used to assay the cognitive function. It consists of 30 points. Lower scores indicate poorer performance and greater cognitive impairment. The total score ranges from 0 to 30.

    Measured: In acute phase, the MMSE is administered at baseline and again at week 6 (or on early termination). In follow-up phase, the MMSE is administered at month 3.

  7. Arizona Sexual Experiences Scale (ASEX)

    The ASEX is used to assay the sexual dysfunction. The ASEX taps five domains of sexual function using 6-point Likert scales scored from 1 (hyperfunction) to 6 (extreme hypofunction) to yield a total score ranging from 5 to 30.

    Measured: In acute phase, the ASEX is rated at baseline and again at week 6 (or on early termination). In follow-up phase, the ASEX is rated at month 3.

  8. Depression and Somatic Symptoms Scale (DSSS)

    The DSSS, a self-rating scale, is used to assay the severity of depression. The DSSS contains 22 items. Item responses are ranked from 0 to 3, with higher scores corresponding to more severe depression.

    Measured: In acute phase, the DSSS is rated at baseline, and again at weeks 1, 2, 3, 4, 5 and 6 (or on early termination). In follow-up phase, the DSSS is rated at months 1, 2, and 3.

  9. The Wechsler Memory Scale (WMS).

    The WMS is designed to measure different memory functions. Higher scores indicate higher memory functions.

    Measured: In acute phase, the WMS is administered at baseline and again at week 6 (or on early termination). In follow-up phase, The WMS is administered at month 3.

Timeline

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

  1. First posted29 Nov 2019
  2. Study start3 Mar 2014
  3. Primary completion8 Oct 2019
  4. Study completion22 Nov 2019

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04181567
Sponsor's protocol ID
MOST-103-2314-B-280-001-MY3
Other IDs
KSPH-2013-36
Status last verified
Nov 2019
First submitted
24 Nov 2019
Last updated
29 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Lin CH, Yang WC, Chan MH, Chen CC. The Relationship Between Depression and Pain During Acute Electroconvulsive Therapy and Follow-Up Period for Patients With Treatment-Resistant Depression. J ECT. 2022 Sep 1;38(3):192-199. doi: 10.1097/YCT.0000000000000830. Epub 2022 Mar 1.

    PubMed 35220359

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing electroconvulsive therapy and agomelatine in people with Major Depressive Disorder, run by Kaohsiung Kai-Suan Psychiatric Hospital at 1 site in Taiwan.

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 6 inclusion and 6 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: finished, as of the sponsor's last update on 29 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 Taiwan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

17-item Hamilton Rating Scale for Depression (HAMD-17) (time frame: up to month 3.). 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 NCT04181567, which also lists 1 linked publication.

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 29 Nov 2019.

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