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Clinical trials for Acute Mania AND Mania

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
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  • 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   44334   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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    39 result(s) found for: Acute Mania AND Mania. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-000281-23 Sponsor Protocol Number: Oxford University(None) Start Date*: 2009-09-10
    Sponsor Name:University of Oxford
    Full Title: Melatonin in Acute Mania Investigation (MIAMI-UK)
    Medical condition: Bipolar Disorder (mania and hypomania)
    Disease: Version SOC Term Classification Code Term Level
    12 10000852 Acute Mania LLT
    12 10021030 Hypomania LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-023992-24 Sponsor Protocol Number: MEMAP1 Start Date*: 2011-08-26
    Sponsor Name:University of Leipzig
    Full Title: International randomised double-blind placebo-controlled study on the initial treatment of acute mania with methylphenidate
    Medical condition: acute mania and hypomania (ICD-10: F30.0, F30.1, F31.0, F31.1)
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004873 10000852 Acute mania LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) BE (Completed) HU (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: 2004-001482-17 Sponsor Protocol Number: F1D-MC-HGKQ(b) Start Date*: 2004-10-15
    Sponsor Name:Eli Lilly and Company
    Full Title: Olanzapine Versus Divalproex and Placebo in the Treatment of Mild to Moderate Mania Associated with Bipolar I disorder.
    Medical condition: Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: View results
    EudraCT Number: 2008-007190-20 Sponsor Protocol Number: D144AC00003 Start Date*: 2009-12-14
    Sponsor Name:AstraZeneca AB
    Full Title: An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR™ (Quetiapine Fumarate) i...
    Medical condition: Acut mania in subjects with bipolar I disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004939 Bipolar I disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-018409-13 Sponsor Protocol Number: P05691 Start Date*: 2012-08-23
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering
    Full Title: A Phase 3b, Multicenter, Double-Blind, Fixed-Dose, Parallel-Group, Three Week Placebo Controlled Trial Evaluating the Safety and Efficacy of Asenapine in Subjects With Bipolar 1 Disorder Experie...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-006426-26 Sponsor Protocol Number: D1443L00009 Start Date*: 2007-01-17
    Sponsor Name:AstraZeneca AB
    Full Title: FAST – A randomised, open-label, parallel, multicentre Phase IIIb Study to evaluate the Efficacy and Safety of Quetiapine IR titrared over 4 Days in Patients with Acute Psychosis (Rapid versus Conv...
    Medical condition: Patients requiring treatment, as judged by the Investigator, for an acute episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV criteria).
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-002133-13 Sponsor Protocol Number: PRA/BIA-2093-204 Start Date*: 2005-10-21
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN A DOUBLE-BLIND, FIXED MULTIPLE DOSE, RANDOMIZED, PLACEBO-CONTROLLED, MULTICE...
    Medical condition: Patients with acute manic episodes fulfilling DSM-IV criteria for Bipolar I Disorder.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-005072-32 Sponsor Protocol Number: R&D2004/39 Start Date*: 2005-12-19
    Sponsor Name:Kings College London (IOP) / South London and Maudsley NHS Trust (Co-sponsorship)
    Full Title: Is it possible to modify the course of manic relapse? A pilot study of the effectiveness of quetiapine in preventing the development of manic episodes in Bipolar Disorder.
    Medical condition: Bipolar Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-005010-37 Sponsor Protocol Number: 62 Start Date*: 2005-08-16
    Sponsor Name:Suffolk Mental Health Partnerships Trust
    Full Title: Enhancing cognition in bipolar disorder
    Medical condition: Bipolar affective disorder, currently in remission
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002222-20 Sponsor Protocol Number: 331-201-00080 Start Date*: 2018-02-23
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-002190-20 Sponsor Protocol Number: 331-201-00081 Start Date*: 2018-04-09
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Multicenter, Randomized, Double-blind Trial of Brexpiprazole versus Placebo for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
    Medical condition: Treatment of Manic Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HR (Completed)
    Trial results: View results
    EudraCT Number: 2005-004357-94 Sponsor Protocol Number: NPS-2005-1 Start Date*: 2006-01-20
    Sponsor Name:Nordfjord Psychiatric Centre
    Full Title: Escitalopram in bipolar depression: a placebo-controlled study of acute and maintenance treatment.
    Medical condition: Patients with bipolar disorder in a depressive episode are randomised to receive escitalopram or placebo for eight weeks. Responders to escitalopram are re-randomised to placebo or escitalopram for...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000405-83 Sponsor Protocol Number: VP-VYV-683-3201 Start Date*: 2021-04-09
    Sponsor Name:Vanda Pharmaceuticals Inc.
    Full Title: A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of iloperidone for 4 weeks in the treatment of patients with acute manic episodes associated wi...
    Medical condition: Acute manic episodes associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-006706-69 Sponsor Protocol Number: DUAG9V1.03_10.06.2022 Start Date*: 2022-06-22
    Sponsor Name:Psychiatry – Aalborg University Hospital, Unit for Psychiatric Research
    Full Title: Lithium versus cariprazine in the acute phase treatment of bipolar depression: a pragmatic head-to-head open, randomized multicenter study. The 9th study of the Danish University Antidepressant Gro...
    Medical condition: Bipolar disorder, current depressive episode.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10004911 Bipolar affective disorder, depressed LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-004391-21 Sponsor Protocol Number: A1281147 Start Date*: 2006-06-23
    Sponsor Name:Pfizer S.A.
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY, COMPARING THE EFFICACY AND TOLERABILITY OF ZIPRASIDONE (ZELDOX®, GEODON®) VS OLANZAPINE (ZYPREXA®) IN THE TREATMENT AND MAINTENANCE OF...
    Medical condition: Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.1 10004939 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) GR (Prematurely Ended) DE (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001541-18 Sponsor Protocol Number: T3RIS22007 Start Date*: 2007-10-08
    Sponsor Name:Institute of Psychophysiology and Rehabilitation (IRP) of the Kaunas University of Medicine
    Full Title: Triiodothyronine as an adjunct in treatment of acute schizophrenia
    Medical condition: Acute Schizoprenia episode
    Disease: Version SOC Term Classification Code Term Level
    9.1 10001065 Acute schizophrenia episode LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: LT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-001308-11 Sponsor Protocol Number: F1D-XM-HGLW Start Date*: 2004-08-19
    Sponsor Name:Lilly.S.A.
    Full Title: Optimal Treatment Duration with Olanzapine following Remission of Manic or Mixed Episode. An Open-Label, Randomized Trial Comparing Two Treatment Strategies
    Medical condition: to compare the efficacy in the prevention of relapse to manic, depressive, or mixed episodes in two groups of bipolar I patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022647-38 Sponsor Protocol Number: P06107 Start Date*: 2011-11-16
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation
    Full Title: Efficacy and Safety of 3-Week Fixed-Dose Asenapine Treatment in Pediatric Acute Manic or Mixed Episodes Associated with Bipolar I Disorder (Protocol No. P06107)
    Medical condition: Acute Manic or Mixed Episodes Associated with Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    14.0 10037175 - Psychiatric disorders 10068455 Bipolar I disorder, hypomanic LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-002131-27 Sponsor Protocol Number: SCO/BIA-2093-203 Start Date*: 2005-09-27
    Sponsor Name:BIAL - Portela & Ca, S.A.
    Full Title: Efficacy and safety of eslicarbazepine acetate (BIA 2-093) in acute manic episodes associated with bipolar I disorder in a double-blind, randomised, dose-titration, placebo-controlled, multicenter ...
    Medical condition: Patients with acute manic episode fulfilling DSM-IV criteria for Bipolar I Disorder (i.e., 296.0, 296.4 or 296.6)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) CZ (Completed) DE (Completed) PT (Completed)
    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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