Evaluation of niacin addition to Escitalopram in patients with depression
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 1 on 66 patients. Online website (https://www.sealedenvelope.com) will be used for randomization.
Settings and conduct
The study is conducted in a double-blind manner at the neuropsychiatric clinic of Golestan Hospital, Ahvaz. The patients are divided into two groups of 33 people, they are subjected to S-citalopram with niacin or S-citalopram with placebo, and after eight weeks, its effect on back pain and its complications are investigated in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: score 18 to 11 in the Hamilton depression test, diagnosis of mild and moderate depression based on structured interview based on DSM-5 and Hamilton index, age 10 to 68 years.
Exclusion criteria: In case of electric shock in the last two months, thyroid diseases, psychotic disorder, pregnant mothers, severe depression, allergy to niacin.
Intervention groups
Intervention group: The intervention group (33 people) will receive niacin supplement in addition to citalopram as an anti-depressant drug. Niacin supplementation starts with half a gram and increases half a gram every 0 weeks.
Control group: The control group (33 people) will receive a placebo in addition to S-citalopram for eight weeks. The evaluation will be done by a psychiatrist. Escitalopram drug started with 6 mg daily and reached 18 mg in the second week.
Main outcome variables
Depression score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231207060286N1
Registration date:2023-12-17, 1402/09/26
Registration timing:prospective
Last update:2023-12-17, 1402/09/26
Update count:0
Registration date
2023-12-17, 1402/09/26
Registrant information
Name
Gholamhasan Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 572 4252
Email address
esfahani.gh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-09, 1402/10/19
Expected recruitment end date
2024-03-09, 1402/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of niacin addition to Escitalopram in patients with depression
Public title
The effect of niacin in the treatment of depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Score 11 to 18 in Hamilton depression test
Diagnosis of mild and moderate depression based on structured interview based on DSM-5 and Hamilton index
Age 18 to 60 years
Exclusion criteria:
Received electric shock in the last two months
Thyroid diseases
Psychotic disorder
pregnant women
severe depression
Allergy to niacin
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Patients with eligibility criteria will be divided into two groups using a randomized block design. An online website (https://www.sealedenvelope.com) is used to generate a random list based on the desired sample size and block size of 4. After creating a list, each patient will be identified with a unique code throughout the study. 33 people are selected for the intervention group and 33 people for the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be evaluated by another specialist as part of the main research, and the design will be done in a double-blind manner. The patients' medications are adjusted by a nurse unrelated to the research and given to the patients so that the patients will not know the type of medication they are taking.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundishapur Ahvaz University of Medical Sciences
Street address
Golestan BLVD
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Approval date
2023-11-27, 1402/09/06
Ethics committee reference number
IR.AJUMS.REC.1402.447
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32.0
ICD-10 code description
Major depressive disorder, single episode, mild
Primary outcomes
1
Description
Depression score
Timepoint
Before the intervention, 2, 4, and 8 weeks after the intervention
Method of measurement
Clinical examination with Hamilton's index
Secondary outcomes
1
Description
Side effects of niacin
Timepoint
Before the intervention, 2, 4, and 8 weeks after the intervention
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group: The intervention group (33 people) will receive niacin (Abidi Pharmaceuticals co.) supplement in addition to EScitalopram (Abidi Pharmaceuticals co.) as an anti-depressant drug. Niacin supplementation starts with half a gram and increases half a gram every 0 weeks.
Category
Treatment - Drugs
2
Description
Control group: The control group (33 people) will receive a placebo in addition to the EScitalopram (Abidi Pharmaceuticals co.) drug for eight weeks. The evaluation will be done by a psychiatrist. Escitalopram drug started with 6 mg daily and reached 18 mg in the second week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology and Psychiatry Clinic, Golestan Ahvaz Hospital
Full name of responsible person
Gholamhasan Esfahani
Street address
Golestan BLVD
City
Ahvaz
Province
Khouzestan
Postal code
6441945781
Phone
+98 915 572 4252
Email
esfahani.gh@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
Golestan BLVD
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Email
zakerkish-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhasan Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 915 572 4252
Fax
Email
esfahani.gh@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhasan Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 915 572 4252
Fax
Email
esfahani.gh@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhasan Esfahani
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 915 572 4252
Fax
Email
esfahani.gh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
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