Verified June 2017 by Gokhan Ozdemir, Kahramanmaras Sutcu Imam University
Information provided by (Responsible Party):
Gokhan Ozdemir, Kahramanmaras Sutcu Imam University
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure|
- Intraocular pressure [ Time Frame: One month ]
|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)|
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.
- Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.
– Any past history of ocular surgery, ocular trauma or existing ocular diseases
Please refer to this study by its ClinicalTrials.gov identifier: NCT03193112
|Kahramanmaras Sutcuimam University Ophthalmology Department|
|Kahramanmaraş, Turkey, 46050|
|Contact: Gokhan Ozdemir, MD 3443003312 email@example.com|
|Contact: Ebru Fındıklı, MD 3003434 firstname.lastname@example.org|
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:
Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Hypnotics and Sedatives
ClinicalTrials.gov processed this record on June 20, 2017