L-Theanine combination therapy with Fluvoxamine in moderate to severe obsessive-compulsive disorder: A placebo-controlled, double-blind, randomized trial
L-Theanine combination therapy with Fluvoxamine in the treatment of moderate to severe obsessive-compulsive disorder
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be performed on patients with moderate to severe obsessive-compulsive disorder attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 60 years old; diagnosis of moderate to severe OCD based on DSM-5; score of >21 in Yale–Brown obsessive-compulsive scale (Y-BOCS). Exclusion criteria: receiving any treatment up to 6 weeks before the start of the trial; presence of another psychiatric disorder.
Intervention groups
Patients with moderate to severe obsessive-compulsive disorder (based on DSM-5 diagnostic criteria) are included in the study and divided into two control (25 participants) and intervention (25 participants) groups. All patients are treated with Fluvoxamine 100 mg daily for the first four weeks and then 200 mg daily until the end of the tenth week. L-Theanine100 mg twice/day will be given to patients. In the control group, patients will receive a placebo, twice/day. Patients are evaluated at weeks 0, 5, and 10 by Yale-Brown obsessive-compulsive scale (Y-BOCS).
Main outcome variables
Severity of obsessive-compulsive disorder (OCD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N134
Registration date:2020-12-12, 1399/09/22
Registration timing:prospective
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-20, 1399/11/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
L-Theanine combination therapy with Fluvoxamine in moderate to severe obsessive-compulsive disorder: A placebo-controlled, double-blind, randomized trial
Public title
L-Theanine for the treatment of obsessive-compulsive disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 60 years
Diagnosis of moderate to severe OCD based on DSM-5
Score of >21 in Yale–Brown obsessive-compulsive scale (Y-BOCS)
Exclusion criteria:
Receiving any treatment up to 6 weeks before the start of the trial
Presence of another psychiatric disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size ("A" and "B" are the study groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-08-21, 1399/05/31
Ethics committee reference number
IR.TUMS.DDRI.REC.1399.023
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of OCD symptoms
Timepoint
Baseline and weeks 5 and 10
Method of measurement
By Yale–Brown obsessive-compulsive scale (Y-BOCS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fluvoxamine tablet (Sobhan darou co.) 100 mg daily for the first 4 weeks and 200 mg daily for the next 6 weeks + L-Theanine (Institute of Medicinal Plants) tablet 100 mg BID, for 10 weeks
Category
Treatment - Drugs
2
Description
Control group: Fluvoxamine tablet (Sobhan darou co.) 100 mg daily for the first 4 weeks and 200 mg daily for the next 6 weeks + Placebo tablet BID, for 10 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Prof. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
users should cite the resource of data
From where data/document is obtainable
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document