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Clinical trials for Psychomotor agitation

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    11 result(s) found for: Psychomotor agitation. Displaying page 1 of 1.
    EudraCT Number: 2022-000943-59 Sponsor Protocol Number: 280482 Start Date*: 2022-12-22
    Sponsor Name:Odense University Hospital, anaeshtesiologic intensive ward V
    Full Title: Autonome-nervous system regulated anaesthesia: A randomized controlled trial comparing dexmedetomedine and placebo in heart rate variability monitored children
    Medical condition: Postoperative agitation
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10001499 Agitation mental LLT
    21.1 100000004852 10056436 Psychomotor agitation LLT
    20.1 100000004863 10079742 Agitation on recovery from sedation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-001466-10 Sponsor Protocol Number: MY-clonidin-1 Start Date*: 2014-10-10
    Sponsor Name:Copenhagen University Hospital, Rigshospitalet, Juliane Marie Centre, Department of Anaesthesiology
    Full Title: does intraoperative clonidine reduce postoperative agitation in children anaesthetized with sevofluran? A RCT including pharmacokinetic investigation
    Medical condition: postoperative agitation
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004852 10056436 Psychomotor agitation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2014-001157-17 Sponsor Protocol Number: PSI-HAL-2014 Start Date*: 2014-07-29
    Sponsor Name:Fundació Parc Taulí
    Full Title: Efficacy and safety of intranasal administration of haloperidol in agitated schizophrenic patients: a controlled, blinded, randomized and single-center clinical trial
    Medical condition: Agitation in schizophrenic patients
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001339-38 Sponsor Protocol Number: 17-AVP-786-305 Start Date*: 2018-01-22
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-design study to assess the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide [d6-DM]/qui...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) GB (GB - no longer in EU/EEA) CZ (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-003331-36 Sponsor Protocol Number: FER-Loxapine-2015-01 Start Date*: 2016-03-16
    Sponsor Name:FERRER INTERNACIONAL SA
    Full Title: A Phase IV, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety of self-administered ADASUVE(R) (Staccato loxapine for inhalation) in Agitated Patients outside the hospital setting
    Medical condition: Mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2017-002455-29 Sponsor Protocol Number: 15-AVP-786-303 Start Date*: 2018-07-31
    Sponsor Name:Avanir Pharmaceuticals, Inc.
    Full Title: A Phase 3, Multicenter, Long-term, Extension Study of the Safety and Efficacy of AVP-786 (deuterated [d6] dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the Treatment of Agitation...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Ongoing) FR (Completed) PL (Completed) BG (Completed) CZ (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007384-17 Sponsor Protocol Number: 3005099 Start Date*: 2009-11-30
    Sponsor Name:Sten Walther
    Full Title: A prospective, multi-centre, randomised, double-blind, placebo-controlled comparison of intravenous dexmedetomidine with haloperidol in treatment of hyperactive delirium after heart surgery.
    Medical condition: Postoperative hyperactive delirium
    Disease: Version SOC Term Classification Code Term Level
    12.0 10000702 Acute delirium LLT
    12.0 10049989 Agitation postoperative LLT
    12.0 10056436 Psychomotor agitation LLT
    12.0 10049987 Confusion postoperative LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001056-17 Sponsor Protocol Number: 3606 Start Date*: 2020-08-14
    Sponsor Name:Kings's College London [...]
    1. Kings's College London
    2. South London and Maudsley NHS Foundation Trust
    Full Title: A randomised feasibility trial investigating Sativex® for the treatment of the Agitation & Aggression (A/A) in Alzheimer’s Dementia.
    Medical condition: Clinically significant agitation in Alzheimer's Diseases
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10001499 Agitation mental LLT
    20.0 10037175 - Psychiatric disorders 10001497 Agitation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-000991-13 Sponsor Protocol Number: STH19610 Start Date*: Information not available in EudraCT
    Sponsor Name:Sheffield Teaching Hospitals NHS Foundation Trust
    Full Title: The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): A Multicentre, Parallel Randomised Controlled Trial of Melatonin Versus Midazolam in the Premedication of Anxious C...
    Medical condition: Anxiety pre-general anaesthesia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10002869 Anxiety symptoms HLT
    20.1 10022117 - Injury, poisoning and procedural complications 10054711 Postoperative pain LLT
    20.1 10022117 - Injury, poisoning and procedural complications 10049989 Agitation postoperative PT
    20.0 10037175 - Psychiatric disorders 10002855 Anxiety PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-004097-15 Sponsor Protocol Number: GabA-01 Start Date*: 2015-10-23
    Sponsor Name:Wilhelminenspital
    Full Title: A single center, prospective, randomized, double blind, placebo-controlled, three-way cross-over study of the analgesic effects of Midazolam versus Placebo with Fentanyl as an active control in hum...
    Medical condition: nociceptive pain
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000256-33 Sponsor Protocol Number: Ra-P-OCD-01 Start Date*: 2019-06-27
    Sponsor Name:Uppsala University Hospital
    Full Title: A randomized, double-blinded, placebo-controlled study of Rituximab in patients with Psychosis and/or Obsessive Compulsive Disorder, with an indication of immune system involvement
    Medical condition: Obsessive-compulsive disorder (OCD) or Obsessive-compulsive behaviour (OCB) or psychotic disorder (PD) in which there is an indication of immune system involvement.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10029898 Obsessive-compulsive disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
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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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