Efficacy of caffeine supplementation in patients with obsessive-compulsive disorder treated with Selective serotonin reuptake inhibitors (SSRIs)
with partial response
Design
In this study, a phase 3, duble blind randomized controled clinical trial , 130 patients suffering from obsessive-compulsive disorder who were treated with serotonin reuptake inhibitor drugs with a random assignment software in two groups of 65 people distributed to the intervention group people who received caffeine tablets with a dose of 100 mg for one week and 200 mg in the second week and then 300 mg once a day. People in the control group will be given a placebo pill with the same form and protocol.
Settings and conduct
This double-blind study (where patients and researchers are unaware of the type of drug prescribed) will be conducted in 1405 and 1406 at Noor and Hazrat Ali Asghar Hospital in Isfahan. 130 patients with obsessive-compulsive disorder who are treated with serotonin reuptake inhibitors are divided into two groups receiving caffeine and placebo.
Participants/Inclusion and exclusion criteria
In this study, patients with obsessive-compulsive disorder who have been treated with serotonin reuptake inhibitor drugs for at least 12 weeks and who do not have psychotic thoughts addiction and do not have contraindications to opioid use are included in the study.
Intervention groups
In the intervention group, caffeine tablets with a dose of 100 mg will be given for one week, then 200 mg in the second week, and then 300 mg once a day, and placebo tablets with the same shape and protocol will be added to the control group.
Main outcome variables
Obsessive compulsive score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090801002266N23
Registration date:2026-05-31, 1405/03/10
Registration timing:registered_while_recruiting
Last update:2026-05-31, 1405/03/10
Update count:2
Registration date
2026-05-31, 1405/03/10
Registrant information
Name
Gholamreza Kheirabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 2135
Email address
kheirabadi@bsrc.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-22, 1405/03/01
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
Effectiveness of Caffeine Augmentation in Partial-Response Obsessive Compulsive disorder Patients Treated with Selective serotonin reuptake inhibitors (SSRIs)
Public title
Evaluation of adding Cafein to SSRI in pationts with Obsessive-Compulsive Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
CD diagnosis based on clinical interview based on DSM5 clinical criteria
Outpatients with at least 12 weeks (3 months) of SSRI treatment and partial response.
Ability to read and write
Patient consent to participate in the study
Exclusion criteria:
Pregnancy
Drug abuse (based on patient report or file contents)
Existence of suicidal thoughts (based on the report or content of the patient's file)
The presence of psychotic symptoms based on the patient's report
Diseases that can prevent the use of caffeine
Taking other medications along with an SSRI, including antipsychotics, anticonvulsants, stimulants, or other augmenting medications, or taking more than one type of SSRI
Excessive caffeine consumption
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients between two groups is done with random assignment software. In this software, the total volume of the sample and the number of groups are entered into the software. The output of the software is a list that shows the total number of samples numerically and randomly distributed in two groups. Patients are distributed in two groups according to the time of visit and according to the mentioned list, so that the sample size reaches the required number.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was double-blind, and the researcher and the patients were unaware of the type of drug received. Allocation of drug packages to patients will be done by the pharmacist using random coding. The researchers will only receive the random code and will not know the drug or placebo content until the end of the data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Approval date
2026-02-20, 1404/12/01
Ethics committee reference number
IR.MUI.MRD.REC.1404.466
Health conditions studied
1
Description of health condition studied
Obsessive Compolsive Disorder
ICD-10 code
F42.0
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Obsessive Compulsive disorder scale
Timepoint
At statrt and end of intervention
Method of measurement
With Y-BOCS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Received Cafeine 100 mg for one week, then 200 mg cafeine for tnd week and then 300 mg cafeine for third week.
Category
Treatment - Drugs
2
Description
Control group: Received plaseboo for three weeks same to intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor & Ali Asghar hospital
Full name of responsible person
Gholamreza KHeirabadi
Street address
Noor & Ali Asghar hospital, Ostandari street, isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
kheirabadi@bsrc.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Research faculty, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
843419347
Phone
+98 31 3792 3060
Email
askari@ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Clinical psychology department, Noor & Ali Asghar hospital, Ostandari street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
kheirabadi@bsrc.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Kheirabadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Department of clinical psychology, Noor & Ali Asghar hospital, Ostandari street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3669 2174
Email
kheirabadi@bsrc.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ali Mehrabi
Position
Statistical Consultant
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Research faculty, medical school, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8434193474
Phone
+98 31 3792 9520
Email
al.mehrabi@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
The plan bellonging to goverment and we cant sharing it.