5-hydroxytryptophan combination therapy with fluoxetine in the treatment of moderate to severe OCD: a double blind randomized trial with placebo control
The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of 5-hydroxytryptophan would improve psychopathology in subjects with OCD treated with fluoxetine
Design
randomized, double-blind, placebo controlled study
Settings and conduct
The study will be conducted among patients attending Roozbeh Hospital-Tehran
Participants/Inclusion and exclusion criteria
1- Age between 18-60 years old; 2- Diagnosis of OCD based on DSM-5; 3- Minimum Score of 21 on YALE-BROWN Obsessive-Compulsive Scale
Intervention groups
Fluoxetine 60 mg per day+ 5-hydroxytryptophan100mg BID for 12 weeks as intervention group
Main outcome variables
Severity of symptoms of OCD
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N106
Registration date:2018-04-05, 1397/01/16
Registration timing:prospective
Last update:2018-04-05, 1397/01/16
Update count:0
Registration date
2018-04-05, 1397/01/16
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
2018-04-19, 1397/01/30
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
5-hydroxytryptophan combination therapy with fluoxetine in the treatment of moderate to severe OCD: a double blind randomized trial with placebo control
Public title
5-hydroxytryptophan in treatment of moderate to severe OCD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years old
Diagnosis of OCD based on DSM-5
inimum Score of 21 on YALE-BROWN Obsessive-Compulsive Scale
Exclusion criteria:
Substance dependence
IQ less than 70
Any other mental disorder
Any serious cardiac, renal or hepatic disease
receiving psychotropic medications during the last 6 weeks
pregnancy or breast feeding
Rising liver transaminases to three times the upper limit of normal or higher
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocks ( each block has four cases)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome evaluators will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشكي تهران
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-03-10, 1396/12/19
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4661
Health conditions studied
1
Description of health condition studied
Obsessive- Cumpulsive Disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Severity of symptoms of OCD
Timepoint
Baseline and weeks: 4, 8, 12 after beginnig of treatment
Method of measurement
Y_BOCS( Yale-Brown obsessive compulsive scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fluoxetine 60 mg/day+ 5-hydroxytryptophan 100 mg BID for 12 weeks as intervention group
Category
Placebo
2
Description
Control group: Fluoxetine 60mg per day + placebo for 12 weeks as control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
Roozbeh Hospital, South Kargar Street
City
tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.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
Keshvarz 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?
Yes
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
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street,
City
tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
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
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
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
No - There is not 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
All data will be distributed through final report
When the data will become available and for how long
from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
by email
From where data/document is obtainable
prof Shahin Akhondzadeh
What processes are involved for a request to access data/document