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Melatonin Decreases Eye Pressure in Normotensive Patients

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ClinicalTrials.gov Identifier: NCT03193112
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Gokhan Ozdemir, Kahramanmaras Sutcu Imam University

Brief Summary:
Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases intraocular pressures when given depressive patients.

Condition or disease Intervention/treatment
Depressive Disorder Drug: Agomelatine 25 MG Oral Tablet

Detailed Description:
Melatonin has been shown to be effective to decrease intraocular pressure in experimental animal researches. Agomelatine is a melatonin derivative drug approved for the treatment of depression, which is also available in our country. Depending on animal experiments, it can be assumed that agomelatine can decrease intraocular pressure. Demonstrating that agomelatine is effective to reduce eye pressure may give a concurrent treatment of depressive patients with glaucoma. With this it may be possible to treat both diseases at the same time with single drug. In this study, the researchers intended to investigate the changes in ocular tension in normotensive depressive patients treated with agomelatine.

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure
Actual Study Start Date : June 16, 2017
Actual Primary Completion Date : October 15, 2017
Actual Study Completion Date : June 15, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin

Group/Cohort Intervention/treatment
Study group
The investigators analyze the intraocular pressure changes on patients who have been using Agomelatine for their primary depressive disorder. For the treatment of depression, patients will have been started routinely Agomelatine tablet of 25 mg orally. The investigators measure the eye pressure for one months in those patients receiving standard depression treatment.
Drug: Agomelatine 25 MG Oral Tablet
We will treat our patients with Agomelatine tablet of 25 mg.




Primary Outcome Measures :
  1. Intraocular pressure [ Time Frame: One month ]
    mmHg



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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Investigators seek to analyze the intraocular pressure changes depending on Agomelatin treatment. Depressive patients who are deemed suitable for agomelatine treatment on a routine basis by psychiatry clinic will be monitored with regard to intraocular pressure changes. Treatment decision will be given by the psychiatrist independently from patient's enrollment to the study. Then, investigators will measure intraocular pressure before the treatment and one month after the treatment.
Criteria

Inclusion Criteria:

  • Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.

Exclusion Criteria:

- Any past history of ocular surgery, ocular trauma or existing ocular diseases


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03193112


Locations
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Turkey
Kahramanmaras Sutcuimam University Ophthalmology Department
Kahramanmaraş, Turkey, 46050
Sponsors and Collaborators
Kahramanmaras Sutcu Imam University
Investigators
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Principal Investigator: Gokhan Ozdemir, MD KSU

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Responsible Party: Gokhan Ozdemir, Principal investigator, Clinical Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT03193112     History of Changes
Other Study ID Numbers: KahramanmarasSIU
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Gokhan Ozdemir, Kahramanmaras Sutcu Imam University:
Agomelatine
Depression
Intraocular pressure

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Melatonin
S 20098
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Hypnotics and Sedatives