Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Mania AND Bipolar Disorder

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   44356   clinical trials with a EudraCT protocol, of which   7382   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    85 result(s) found for: Mania AND Bipolar Disorder. Displaying page 3 of 5.
    « Previous 1  2  3  4  5  Next»
    EudraCT Number: 2015-000606-20 Sponsor Protocol Number: A1281132 Start Date*: 2015-04-03
    Sponsor Name:Pfizer, Inc.
    Full Title: Four Week, Double-Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Dis...
    Medical condition: Bipolar Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2017-000803-25 Sponsor Protocol Number: RGH-MD-25 Start Date*: 2019-10-02
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED WITHDRAWAL, MULTICENTER CLINICAL TRIAL EVALUATING THE EFFICACY, SAFETY, AND TOLERABILITY OF CARIPRAZINE IN A DOSE-REDUCTION PARADIGM IN THE PREVENTION...
    Medical condition: Bipolar I disorder
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10026753 Manic and bipolar mood disorders and disturbances HLGT
    20.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2011-004789-14 Sponsor Protocol Number: D1050308 Start Date*: 2012-07-04
    Sponsor Name:Sunovion Pharmaceuticals Inc.
    Full Title: A Multicenter, Open-Label, Flexible-Dose Extension Study of Lurasidone Adjunctive to Lithium or Divalproex in Subjects with Bipolar I Disorder
    Medical condition: bipolar disorder I
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) SK (Completed) BG (Completed) PL (Completed) HR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016041-25 Sponsor Protocol Number: RGH-MD-36 Start Date*: 2010-05-12
    Sponsor Name:Forest Research Institute, Inc.
    Full Title: A Long-Term Open-label Study of the Safety and Tolerability of Cariprazine in Patients With Bipolar I Disorder
    Medical condition: Bipolar I disorder
    Disease: Version SOC Term Classification Code Term Level
    12.0 10004939 Bipolar I disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) HU (Completed)
    Trial results: View results
    EudraCT Number: 2010-018671-20 Sponsor Protocol Number: P06384 Start Date*: 2012-08-24
    Sponsor Name:Forest Research Institute Inc., a wholly owned subsidiary of Forest Laboratories, LLC
    Full Title: A Double-Blind, Placebo-Controlled Trial of Asenapine in the Prevention of Recurrence of a Mood Episode After Stabilization of an Acute Manic/Mixed Episode in Subjects With Bipolar 1 Disorder (Phas...
    Medical condition: Bipolar 1 Disorder
    Disease: Version SOC Term Classification Code Term Level
    17.1 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: 2005-002134-35 Sponsor Protocol Number: PRA+SCO/BIA-2093-205 Start Date*: 2005-09-27
    Sponsor Name:Bial - Portela & Cª, S.A.
    Full Title: EXTENSION STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF ESLICARBAZEPINE ACETATE (BIA 2-093) IN THE RECURRENCE PREVENTION OF BIPOLAR I DISORDER
    Medical condition: recurrence prevention of bipolar I disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) ES (Completed) CZ (Completed) DE (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004334-42 Sponsor Protocol Number: 31-08-252 Start Date*: 2013-02-14
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients with Bipolar I Disorder
    Medical condition: Bipolar I disorder
    Disease: Version SOC Term Classification Code Term Level
    16.1 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2004-000202-49 Sponsor Protocol Number: CN138-134 Start Date*: 2005-02-22
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: Efficacy of Aripiprazole in Combination with Valproate or Lithium in the Treatment of Mania in Patients with Bipolar I Disorder Partially Nonresponsive to Valproate or Lithium Monotherapy Revised...
    Medical condition: Bipolar disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) HU (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001935-30 Sponsor Protocol Number: ELND005-BPD201 Start Date*: 2012-11-27
    Sponsor Name:Elan Pharma International Ltd
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Safety and Efficacy Study of Oral ELND005 as an Adjunctive Maintenance Treatment in Patients with Bipolar I Disorder
    Medical condition: Bipolar I Disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) LT (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-001472-12 Sponsor Protocol Number: A7501009 Amendment 1 Start Date*: 2006-04-12
    Sponsor Name:N V Organon
    Full Title: A Phase 3, Placebo-Controlled, Double-Blinded Continuation Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Completing Trial A7501008 and Continuing Lithium or Valproic Acid/Divalp...
    Medical condition: Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    8.0 10004939 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-000589-11 Sponsor Protocol Number: F1D-MC-HGKR Start Date*: 2004-08-10
    Sponsor Name:ELI LILLY and COMPANY
    Full Title: Protocol F1D-MC-HGKR. Olanzapine Plus Carbamazepine Versus Carbamazepine Alone in the Treatment of Manic or Mixed Episodes 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: HU (Completed)
    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
    EudraCT Number: 2016-000757-13 Sponsor Protocol Number: RGH-MD-54 Start Date*: 2016-06-07
    Sponsor Name:Forest Laboratories LLC, an Allergan Affiliate
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Fixed-Dose Clinical Trial Evaluating the Efficacy, Safety and Tolerability of Cariprazine in Patients with Bipo...
    Medical condition: Bipolar I Depression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LT (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2019-002213-19 Sponsor Protocol Number: ELICE-BD-O1 Start Date*: 2019-09-19
    Sponsor Name:University of British Columbia
    Full Title: A 6-Week Randomised, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy of Lurasidone Adjunctive Therapy in Improving Cognitive Functioning in Euthymic Bipolar Disorder Pa...
    Medical condition: Euthymic Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar 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: 2004-003781-14 Sponsor Protocol Number: RISBIM3003 Start Date*: 2004-12-02
    Sponsor Name:Johnson & Johnson Pharmaceutical Research and Development
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Risperidone Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar I Disorder,...
    Medical condition: BIPOLAR MANIA
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) SK (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-000915-25 Sponsor Protocol Number: D1447C00144 Start Date*: 2005-04-22
    Sponsor Name:AstraZeneca R&D Sodertalje
    Full Title: Multicenter, Randomized, Parallel-group, Double-blind, Placebo-controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 weeks Maintenanc...
    Medical condition: Bipolar I Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004939 Bipolar I disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002870-30 Sponsor Protocol Number: 31-08-250 Start Date*: 2013-01-13
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 52-week, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Ma...
    Medical condition: Bipolar I disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10004939 Bipolar I disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    « Previous 1  2  3  4  5  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Aug 18 20:41:41 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA