Determining the effectiveness of agomelatine and sertraline in anxiety and/or depression and reducing the number of attacks in patients with PNES.
Design
Clinical trial without a control group, with parallel groups, double-blind, randomized, phase 2 on 34 patients. The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used.
Settings and conduct
After receiving the necessary permits to conduct the clinical trial, the study population will be selected from among the outpatients referred to the neurology clinic of Imam Hossein Hospital in Tehran.Patients with psychogenic non-epileptic seizures are diagnosed by a neurologist. Then, patients will complete the Hamilton questionnaire related to depression and anxiety. Then 34 patients will be randomized into two groups of 17 and each group will be treated with one of two drugs: agomelatine or sertraline. Further, for follow-up, the patients will be visited by a psychiatrist for one month, two months, and three months, and the Hamilton anxiety and depression questionnaire will be completed by them again, and the incidence of seizure attacks will be recorded. Patients and clinical caregivers will be blinded to the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Confirmation of PNES diagnosis by neurologist and psychiatrist
2. Not suffering from a mental disability and pregnancy
3. Age 18-65 years
4. Patient satisfaction
exclusion criteria:
1. Patient's lack of consent to continue participating in the study
2. Confirmation of neurological disorder or other major disorders in addition to anxiety and depression during study
3. Not coming for a follow-up visit.
Intervention groups
Two intervention groups, 1: agomelatine (25-50 mg) or 2: sertraline (50-200 mg)
Main outcome variables
level of anxiety; level of depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230626058586N3
Registration date:2024-02-19, 1402/11/30
Registration timing:registered_while_recruiting
Last update:2024-02-19, 1402/11/30
Update count:0
Registration date
2024-02-19, 1402/11/30
Registrant information
Name
Nasim Sohrabifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 938 229 6766
Email address
nasimsohrabifar@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-19, 1402/11/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparing the efficiency of agomelatine & sertraline in the depression & anxiety of patients suffering from psychogenic non-epileptic seizure (PNES)
Public title
Investigating the effect of agomelatine and sertraline on anxiety and depression
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of PNES diagnosis by neurologist and psychiatrist
Not suffering from mental disability and pregnancy
Age range between 18-65 years
Patient satisfaction
Exclusion criteria:
Patient's lack of consent to continue participating in the study
Confirmation of neurological disorder or other major disorders in addition to anxiety and depression during study
Not coming for a follow-up visit.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
The website www.Randomization.com was used for randomization (online randomization). For this purpose, a simple randomization model was used. The randomization unit was individual and on this website, after specifying the number of intervention groups, which were three groups, and the required number in each of these groups, the website provided us with a random table of repetitions that represented the patient number. To hide the random allocation, central randomization was used. In this method, a random sequence is placed in the possession of an individual or a specific center, and sampling is done in one or more centers at the same time. Based on the order in which the participants entered the study, the researcher contacted the relevant center and asked about the random assignment of the participants to a special group.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study was double-blind and the patients and evaluators were unaware of the type of treatment. Also, the study data analyst only had the codes of the treatment groups (1, 2) and they were not able to distinguish the treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Ethics Committee of Shahid Beheshti University of Medical Sciences, Shahid Beheshti University of Medical Sciences, Arabi St., Student Blvd., Velenjak st., Tehran.
City
Tehran
Province
Tehran
Postal code
1995825466
Approval date
2022-11-01, 1401/08/10
Ethics committee reference number
IR.SBMU.MSP.REC.1401.391
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
2
Description of health condition studied
depression
ICD-10 code
F32.8
ICD-10 code description
Other depressive episodes
Primary outcomes
1
Description
depression
Timepoint
before the intervention and one month, two months and three months after the intervention
Method of measurement
Hamilton questionnaire
2
Description
anxiety
Timepoint
before the intervention and one month, two months and three months after the intervention
Method of measurement
Hamilton questionnaire
Secondary outcomes
1
Description
Seizure attacks
Timepoint
before the intervention and one month, two months and three months after the intervention
Method of measurement
EEG
Intervention groups
1
Description
Intervention group: Agomelatine (25-50mg)
Category
Treatment - Drugs
2
Description
Intervention group: Sertraline (50-200 mg)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam hossein hospital
Full name of responsible person
Roya Vaziri Harami
Street address
Shahid madani street
City
Tehran
Province
Tehran
Postal code
1995825466
Phone
+98 21 7343 0300
Email
md.r.vaziriharami@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Street address
Shahid beheshti University of medical sciences Research Vice-Chancellor, Shahid Beheshti University of Medical Sciences, Arabi St., Daneshjoo Blvd., Volenjak St., Tehran.
City
Tehran
Province
Tehran
Postal code
199852468
Phone
+98 21 2387 1524
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1995825466
Phone
+98 21 7343 0300
Email
md.r.vaziriharami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1995825466
Phone
+98 21 7343 0300
Email
md.r.vaziriharami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Roya Vaziri Harami
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Madani street
City
Tehran
Province
Tehran
Postal code
1995825466
Phone
+98 21 7343 0300
Email
md.r.vaziriharami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available