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Evaluation of effect of treatment by fluoxetine on clinical prognosis in patients with Optic neuritis in comparison between drug and placebo groups.

Protocol summary

Study aim
Evaluation of effect of fluoxetine on the clinical prognosis of Optic neuritis
Design
Randomized clinical trial containing placebo, a double blinded study
Settings and conduct
A hundred patients with Optic neuritis referred to Rasool Akram hospital ophthalmology clinic will be randomly divided equally in drug and placebo study groups. Subjects will be evaluated at the first visit and on the end of the 6th month of the treatment course by physical examination, fundoscopic evaluation, VEP, OCT and perimetry batteries. Patient and interviewer are blinded from the treatment received by patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1)Iranian 2)Age over 18 3)Patients with Optic neuritis Exclusion criteria: 1) Pregnancy 2) History of cataract, glaucoma, congenital eye diseases 3) Fluoxetine or other psychotherapeutics medication history 4) More than 3 weeks delay from onset of the visual signs
Intervention groups
Patients with optic neuritis in two groups: 1)Patients given fluoxetine 20 mg daily 2)Patients given placebo
Main outcome variables
Visual acuity; VEP (Visual evoked potential)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200719048138N1
Registration date: 2020-10-19, 1399/07/28
Registration timing: retrospective

Last update: 2020-10-19, 1399/07/28
Update count: 0
Registration date
2020-10-19, 1399/07/28
Registrant information
Name
Mostafa Soltan Sanjari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 1000
Email address
soltansanjari.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-04, 1398/07/12
Expected recruitment end date
2020-09-02, 1399/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of treatment by fluoxetine on clinical prognosis in patients with Optic neuritis in comparison between drug and placebo groups.
Public title
Evaluation of effect of fluoxetine on the clinical prognosis in patients with Optic neuritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian patients Age over 18 years old Patients diagnosed with Optic neuritis
Exclusion criteria:
History of multiple sclerosis cataract, glaucoma ( open or close angle ) congenital eye diseases such as coloboma and involvement with other disorders effecting the central visual field Patients with past medication history of using fluoxetine or other psychotherapeutics including antidepressants psychological disease medication history of arthemeter، astemizol, cisapride, eliglustat, goserelin, isocarboxazide, artemether, leuprolide, linezolid, lumefantrine, methylene blue, phenelzine, pimozide, procarbazine, selegiline, thioridazine, tranylcypromine Patients diagnosed with autoimmune and collagen vascular diseases Trauma or history of ophthalmologic surgeries Interval between involvement and interview more than 3 weeks Pregnancy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize allocation of patients in each group of study, we'll use the permuted block randomization method by means of blocks with 4 in size. According to the number of patients in each group of study (50 patients in each group and over all 100 cases in the study), 25 blocks of four by means of online website (www.sealedenvelope.com) will produce. For concealment, during randomization we'll use specific codes written on drug or placebo boxes which have been produced by computer. Each patient who enters the study will receive a box of drug or placebo according to the
Blinding (investigator's opinion)
Double blinded
Blinding description
During this study, participant will not be aware about if he receiving the drug or placebo because the shape and other features of boxes of both drugs and placebos are the same. The interviewer and investigator also will not be aware of which patients have received drug or placebo. But the analyzer knows the patients who received drug and the patients who received placebo.
Placebo
Used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Sciences
Street address
Iran University of Medical Sciences (IUMS), Hemmat highway, Tehran, iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-04-11, 1399/01/23
Ethics committee reference number
IR.IUMS.REC.1399.083

Health conditions studied

1

Description of health condition studied
The Optic neuritis
ICD-10 code
H46
ICD-10 code description
Optic neuritis

Primary outcomes

1

Description
1)Visual acuity: precision of vision assessed by snelene chart.
Timepoint
On first visit and 6th month after initiation of treatment
Method of measurement
Visual acuity: snelene chart

2

Description
VEP (Visual evoked potential) test: both time ( latency) and amplitude parameters of VEP test will measure.
Timepoint
On first visit and 6th month after initiation of treatment
Method of measurement
VEP test by means of VEP device

Secondary outcomes

1

Description
OCT: thickness of retina
Timepoint
OCT: on first visit and 6th month after initiation of treatment
Method of measurement
OCT: OCT device

2

Description
Perimetry: percent of scotoma in visual field
Timepoint
Perimetry: On first visit and 6th month after initiation of treatment
Method of measurement
Perimetry: digital perimetry device

Intervention groups

1

Description
Intervention group: Intervention group: receivers of fluoxetine antidepressant, 20 mg daily for 6 month
Category
Treatment - Drugs

2

Description
Control group: Control group: Receivers of placebo of fluoxetine that are resemble exactly in appearance features to fluoxetine for 6 month
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ophthalmology research center of Rasool Akram hospital
Full name of responsible person
Dr Mostafa Soltan Sanjari
Street address
Ophthalmology research center of Rasool Akram hospital, Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6650 9162
Email
msoltansanjari@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr mostafa soltan sanjari
Street address
Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
14665-354
Phone
+98 21 86709
Fax
+98 21 8805 2248
Email
msoltansanjari@yahoo.com
Grant name
Vice chancellor for research and technology of the Iran University Of Medical Sciences (IUMS)
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Zahra Poormousa
Position
Ophthalmology resident 3PGY
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
zpourmousa@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Poormousa
Position
Ophthalmology resident 3PGY
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
zpourmousa@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zahra Poormousa
Position
Ophthalmology resident 3PGY
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Eye research center of Rasool Akram hospital, Nyayesh street, Sattarkhan, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
zpourmousa@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
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
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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