Depressive DisorderNCT03193112
Melatonin Decreases Eye Pressure in Normotensive Patients
An observational study of Depressive Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Agomelatine 25 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2017to 15 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.
Who cannot join
- Any past history of ocular surgery, ocular trauma or existing ocular diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaras Sutcuimam University Ophthalmology Department
Kahramanmaraş, 46050
About this study
Official title: Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure
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.
Read the 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.
- Conditions
- Depressive Disorder
- Being tested
- Agomelatine 25 MG Oral Tablet
- Keywords
- Agomelatine, Depression, Intraocular pressure
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agomelatine 25 MG Oral TabletDrug
We will treat our patients with Agomelatine tablet of 25 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Agomelatine 25 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
mmHg
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2017
- Study start16 Jun 2017
- Primary completion15 Oct 2017
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gokhan Ozdemir, Kahramanmaras Sutcu Imam University
- Investigators
- Gokhan Ozdemir, MD, Principal investigator, KSU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193112
- Sponsor's protocol ID
- KahramanmarasSIU
- Status last verified
- Aug 2018
- First submitted
- 16 Jun 2017
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03193112
- Acronym / sponsor ID
- KahramanmarasSIU
- Conditions
- Depressive Disorder
- Keywords
- Agomelatine, Depression, Intraocular pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 20 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Drug: Agomelatine 25 MG Oral TabletThe 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. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.
Key exclusion criteria (1 listed)
- Any past history of ocular surgery, ocular trauma or existing ocular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Agomelatine 25 MG Oral TabletWe will treat our patients with Agomelatine tablet of 25 mg. | Drug | Study group |
Primary outcome
Intraocular pressure
Time frame: One month
mmHg
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gokhan Ozdemir, MD principal investigator
KSU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2018.