Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions - Full Text View

Sponsored by:	Medical University of Vienna
Information provided by:	Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00280501

Purpose

There is evidence from a variety of animal studies that choroidal blood flow is under neural control. By contrast, only little information is available from human studies. Recent results indicate that a light/dark transition is associated with a reduction in choroidal blood flow due to an unknown mechanism. We have shown that during unilateral dark/light transitions both eyes react with choroidal vasoconstriction strongly indicating a neural mechanism responsible for the blood flow changes.

Dopamine has been discussed as a chemical messenger for light adaptation. However, dopaminergic effects in the eye are not restricted to synaptic sites of release, but dopamine also diffuses to the outer retinal layers and pigment epithelium. Accordingly, dopaminergic effects also include a modulatory role on retinal vessel diameter and animal studies provide evidence for vasodilatory effects in the choroid. There is evidence that during darkness retinal and choroidal dopamine levels decrease. Accordingly, dopamine could provide a modulatory input to the light/dark transition induced changes of choroidal circulation. The aim of the present study is to test this hypothesis.

Condition	Intervention
Regional Blood Flow Ocular Physiology	Drug: Quetiapine (drug) Drug: Sulpiride (drug) Drug: Placebo

Drug Information available for: Quetiapine Quetiapine fumarate Dopamine Dopamine hydrochloride Sulpiride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

choroidal blood flow [ Time Frame: in total 3x 3 hours ] [ Designated as safety issue: No ]
fundus pulsation amplitude [ Time Frame: in total 3 x 3 hours ] [ Designated as safety issue: No ]

Enrollment:	21
Study Start Date:	August 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Quetiapine	Drug: Quetiapine (drug) Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose Drug: Sulpiride (drug) Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose Drug: Placebo Placebo
2: Active Comparator Sulpiride	Drug: Quetiapine (drug) Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose Drug: Sulpiride (drug) Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose Drug: Placebo Placebo
3: Placebo Comparator Placebo	Drug: Quetiapine (drug) Quetiapine (Seroquel 100mg-film-coated tablet, AstraZeneca Vienna, Austria) Dose: 100 mg tablet oral single dose Drug: Sulpiride (drug) Sulpiride (Dogmatil 200mg-tablet, Synthélabo Groupe, Le Plessis Robinson, France) Dose: one half of 200 mg tablet oral single dose Drug: Placebo Placebo

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men aged between 18 and 35 years, nonsmokers
Body mass index between 15th and 85th percentile
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant
Normal ophthalmic findings, ametropia < 3 Dpt.

Exclusion Criteria:

Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
Treatment in the previous 3 weeks with any drug
Symptoms of a clinically relevant illness in the 3 weeks before the first study day
History of hypersensitivity to the trial drug or to drugs with a similar chemical structure
History or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs
Blood donation during the previous 3 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280501

Locations

Austria
Department of Clinical Pharmacology
Vienna, Austria, 1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Gabriele Fuchsjaeger-Mayrl, MD

Department of Clinical Pharmacology

More Information

Responsible Party:	Department of Clinical Pharmacology, Medical University of Vienna ( Gabriele Fuchsjaeger-Mayrl, MD )
Study ID Numbers:	OPHT-160905
Study First Received:	January 19, 2006
Last Updated:	July 8, 2008
ClinicalTrials.gov Identifier:	NCT00280501
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Vienna:

Sulpiride
Quetiapine
Light/dark transition
Choroidal blood flow

Study placed in the following topic categories:

Sulpiride
Quetiapine
Dopamine

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009