IRCT | Effectiveness of Caffeine Augmentation in Partial-Response Obsessive Compulsive disorder Patients Treated with Selective serotonin reuptake inhibitors (SSRIs)

History

#	Registration date	Revision Id
3	2026-06-13, 1405/03/23	382125
2	2026-06-09, 1405/03/19	381618
1	2026-05-31, 1405/03/10	380059

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Protocol summary

Study aim: 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: 2026-06-10, 1405/03/20

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

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

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.
Study Protocol: No - There is not a plan to make this available
Statistical Analysis Plan: No - There is not a plan to make this available
Informed Consent Form: No - There is not a plan to make this available
Clinical Study Report: No - There is not a plan to make this available
Analytic Code: No - There is not a plan to make this available
Data Dictionary: No - There is not a plan to make this available

Effectiveness of Caffeine Augmentation in Partial-Response Obsessive Compulsive disorder Patients Treated with Selective serotonin reuptake inhibitors (SSRIs)