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Clinical trials for Circadian rhythms

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Circadian rhythms. Displaying page 1 of 1.
    EudraCT Number: 2010-024191-25 Sponsor Protocol Number: CL3-20098-080 Start Date*: 2012-03-30
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10057840 Major depression PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-004520-35 Sponsor Protocol Number: VP-VEC-162-3204 Start Date*: 2012-12-06
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: AN EXTENSION OPEN-LABEL SAFETY STUDY OF A 24-MONTH 20MG DOSE REGIMEN OF TASIMELTEON FOR THE TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER (N24HSWD) IN BLIND INDIVIDUALS WITH NO LIGHT PERCEPTION WHO ...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep- Wake Disorder
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000281-35 Sponsor Protocol Number: VP-VEC-162-3201 Start Date*: 2011-06-09
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Mask, Placebo-Controlled, Parallel Study to Investigate the Efficacy and Safety of 20 mg Tasimelteon versus Placebo in Totally Blind Subjects with N24HSWD followed...
    Medical condition: Blind males or females with no conscious light perception and the complaint of a sleep-wake disorder associated with Non-24 Hour Sleep-Wake Disorder.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-004009-10 Sponsor Protocol Number: CL3-20098-046 Start Date*: 2005-06-29
    Sponsor Name:Institut de Recherches Internationales Servier [...]
    1. Institut de Recherches Internationales Servier
    2. Laboratorios Servier S.L. (For Spain only)
    Full Title: Efficacy of agomelatine (25 mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder. A randomized, double-blind inte...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    3.3 10025453 P.T.
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-002189-39 Sponsor Protocol Number: 161802 Start Date*: 2017-12-11
    Sponsor Name:University of Oxford
    Full Title: A randomised placebo-controlled trial to assess the effect of melatonin on circadian sleep-wake disturbances in ocular disease.
    Medical condition: circadian sleep-wake disturbances associated with ocular disease.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    21.1 10029205 - Nervous system disorders 10009191 Circadian rhythm sleep disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-005475-40 Sponsor Protocol Number: VP-VEC-162-3502 Start Date*: 2022-06-08
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A multicenter, double-blind, randomized study to evaluate the effects of tasimelteon vs. placebo in participants with Delayed Sleep-Wake Phase Disorder (DSWPD)
    Medical condition: Delayed Sleep-Wake Phase Disorder (DSWPD)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029205 - Nervous system disorders 10041013 Sleep-wake schedule disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001976-39 Sponsor Protocol Number: CHDR1227 Start Date*: 2013-07-30
    Sponsor Name:Centre for Human Drug Research
    Full Title: Randomized, open-label, crossover study into the contribution of the intestines and kidney in the diurnal variation of Levofloxacin pharmacokinetics
    Medical condition: The circadian variation in the relative contribution of intestinal uptake and renal elimination of levofloxacin
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005254-30 Sponsor Protocol Number: EuRhythDiaII Start Date*: 2013-12-27
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Multicenter, randomized, double-blind, placebo controlled trial of 2 mg melatonin for circadian phase adjustment and improvement of metabolic control in night shift workers
    Medical condition: Insomnia because of disturbed sleep-work-rhythm
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10032168 Other insomnia LLT
    17.0 10037175 - Psychiatric disorders 10022443 Insomnia related to another mental condition PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002699-98 Sponsor Protocol Number: CB001-OL Start Date*: 2015-04-14
    Sponsor Name:University of Oxford
    Full Title: OxLith: Exploration of the short-term physical and psychological effects of lithium in mood instability
    Medical condition: Bipolar disorder with current mood instability
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10004908 Bipolar affective disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-004450-21 Sponsor Protocol Number: EMR200136-570 Start Date*: 2014-02-07
    Sponsor Name:Merck Serono S.p.A.
    Full Title: Multicenter, open-label, 12 weeks, phaseIV pRospectivE randomized study aimed at evaLuating whether sc IFN beta 1a (Rebif®) administered In the morning may affEct the severity of Flu-like syndrom...
    Medical condition: relapsing multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-000323-86 Sponsor Protocol Number: N/A Start Date*: 2017-05-05
    Sponsor Name:University of Oxford
    Full Title: A randomised, parallel group, double blind, placebo controlled, add on clinical trial to investigate whether the lithium mimetic, ebselen, can reduce symptoms of hypomania and mania in bipolar pati...
    Medical condition: Patients with bipolar disorder meeting DSM-5 criteria for hypomania or mania
    Disease: Version SOC Term Classification Code Term Level
    19.1 10037175 - Psychiatric disorders 10000852 Acute mania LLT
    19.1 10037175 - Psychiatric disorders 10021030 Hypomania PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2009-010642-57 Sponsor Protocol Number: IC4-20098-542 Start Date*: 2009-07-28
    Sponsor Name:Servier Slovensko, spol. s.r.o.
    Full Title: “Efficacy and safety of ValdoxanR given orally once a day for 24 weeks in patients with Major Depressive Disorder.” Open, national, multicentric clinical trial for the evaluation of the antidepress...
    Medical condition: Major Depressive Disorder
    Disease: Version SOC Term Classification Code Term Level
    11.1 10057840 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2012-001104-37 Sponsor Protocol Number: ME/2011/3709 Start Date*: 2014-10-06
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: Pulsed glucocorticoid replacement therapy for patients with adrenocortical insufficiency secondary to Addison’s disease and congenital adrenal hyperplasia
    Medical condition: Addison's disease and Congenital Adrenal Hyperplasia
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10011195 Cortisol LLT
    17.0 100000004848 10020518 Hydrocortisone LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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