Melatonin Decreases Eye Pressure in Normotensive Patients


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This study is currently recruiting participants.

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Verified June 2017 by Gokhan Ozdemir, Kahramanmaras Sutcu Imam University

Sponsor:

Information provided by (Responsible Party):

Gokhan Ozdemir, Kahramanmaras Sutcu Imam University

ClinicalTrials.gov Identifier:

NCT03193112

First received: June 16, 2017

Last updated: June 19, 2017

Last verified: June 2017

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.

Depressive Disorder Drug: Agomelatine 25 MG Oral Tablet

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure

Primary Outcome Measures:

  • Intraocular pressure [ Time Frame: One month ]

    mmHg

Estimated Enrollment: 25
Actual Study Start Date: June 16, 2017
Estimated Study Completion Date: November 15, 2018
Estimated Primary Completion Date: October 15, 2017 (Final data collection date for primary outcome measure)
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.

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.

Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

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.

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03193112

Kahramanmaras Sutcuimam University Ophthalmology Department
Kahramanmaraş, Turkey, 46050
Contact: Gokhan Ozdemir, MD    3443003312    gozdemir@hotmail.com   
Contact: Ebru Fındıklı, MD    3003434    efindikli@ksu.edu.tr   

Kahramanmaras Sutcu Imam University

Principal Investigator: Gokhan Ozdemir, MD KSU

Responsible Party: Gokhan Ozdemir, Principal investigator, Clinical Professor, Kahramanmaras Sutcu Imam University
ClinicalTrials.gov Identifier: NCT03193112     History of Changes
Other Study ID Numbers: KahramanmarasSIU
Study First Received: June 16, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: No

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:

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

ClinicalTrials.gov processed this record on June 20, 2017