To evaluate the effect of citalopram (20 mg/day) on blood pressure and quality of life in patients with resistant hypertension.
Design
A parallel-group, randomized, open-label controlled trial with 60 patients (30 per group). Randomization by ChatGPT-generated sequence with fixed seed; sequential allocation.
Settings and conduct
This pilot study will be conducted at the clinic of Shahid Madani Hospital, Tabriz. Eligible patients with resistant hypertension will be enrolled consecutively. They will be allocated to intervention (n=30) or control (n=30) groups. The intervention group will receive citalopram 20 mg/day added to their existing triple antihypertensive therapy for 2 months. The control group will continue their triple antihypertensive therapy alone. Blood pressure will be measured at baseline, 1 month, and 2 months. Quality of life (SF-12) and psychological status (DASS-21) will be assessed at baseline and at 2 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with resistant hypertension referred to the clinic.
Non-inclusion criteria:
· Lack of consent or follow-up possibility
· Secondary hypertension
· Contraindication or hypersensitivity to citalopram/SSRIs
· Pregnancy or breastfeeding
· Concurrent serotonergic drugs or drug interactions
· Severe renal or advanced liver disease
Intervention groups
Intervention group:
Citalopram 20 mg/day added to their existing triple antihypertensive therapy for 2 months. Blood pressure measured at baseline, 1, and 2 months. Quality of life assessed at baseline and 2 months.
Control group:
Continues existing triple antihypertensive therapy alone for 2 months. Blood pressure and quality of life assessed at the same time points.
Main outcome variables
Change in systolic and diastolic blood pressure from baseline to 2 months; Change in quality of life score (SF-12) from baseline to 2 months.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260719070255N1
Registration date:2026-08-06, 1405/05/15
Registration timing:registered_while_recruiting
Last update:2026-08-06, 1405/05/15
Update count:0
Registration date
2026-08-06, 1405/05/15
Registrant information
Name
Midia Rashidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3338 1217
Email address
midiarashidi00@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-07-23, 1405/05/01
Expected recruitment end date
2027-03-20, 1405/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of citalopram on blood pressure and quality of life in patients with resistant hypertension
Public title
Effect of citalopram on resistant hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with resistant hypertension who refer to the clinic.
Exclusion criteria:
Lack of informed consent or inability to comply with follow-up visits
Diagnosed secondary hypertension
History of hypersensitivity or contraindication to citalopram or other SSRIs
Pregnancy or breastfeeding
Concurrent use of serotonergic drugs or other medications with potential interaction with citalopram
Severe renal impairment or advanced liver disease
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible patients will be randomly allocated to intervention and control groups in a 1:1 ratio using a randomization sequence generated by an artificial intelligence model (ChatGPT). The AI-generated random sequence will be produced with a fixed seed to ensure reproducibility. The allocation will be performed sequentially at the time of patient enrollment using the generated random list.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2026-06-10, 1405/03/20
Ethics committee reference number
IR.TBZMED.REC.1405.153
Health conditions studied
1
Description of health condition studied
Resistant hypertension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Percentage of patients with resistant hypertension
Timepoint
At baseline, at 1 month, and at 2 months
Method of measurement
Aneroid sphygmomanometer
2
Description
Change in quality of life score
Timepoint
Baseline, and at 2 months
Method of measurement
12-Item Short-Form Health Survey
Secondary outcomes
1
Description
Change in psychological status score
Timepoint
Baseline, and at the end of 2 months
Method of measurement
Depression, Anxiety and Stress Scale - 21 Items
Intervention groups
1
Description
Intervention group: Patients in this group will receive citalopram 20 mg/day orally, added to their existing triple antihypertensive therapy. The treatment will continue for 2 months. Blood pressure will be measured at baseline, 1 month, and 2 months. Quality of life (SF-12) and psychological status (DASS-21) will be assessed at baseline and at the end of 2 months.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will continue their existing triple antihypertensive therapy alone, without any additional medication, for 2 months. Blood pressure will be measured at baseline, 1 month, and 2 months. Quality of life (SF-12) and psychological status (DASS-21) will be assessed at baseline and at the end of 2 months.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani hospital
Full name of responsible person
Dr Hosein Namdar
Street address
Shahid Madani Hospital, Imam Khomeini St., Daneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
research-vice@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Adibkia
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Midia Rashidi
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
midiarashidi00@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hosein Namdar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
hossein_namdar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hosein Namdar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 1249
Email
hossein_namdar@yahoo.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
This is a pilot study with a small sample size (60 patients). Individual participant data (IPD) will not be shared due to the pilot nature of the study and confidentiality considerations.
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
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