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Clinical trials for Mood Disorder AND 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   44349   clinical trials with a EudraCT protocol, of which   7376   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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    55 result(s) found for: Mood Disorder AND Mania AND Bipolar Disorder. Displaying page 2 of 3.
    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: 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: 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: 2013-002055-15 Sponsor Protocol Number: J81J1100168007 Start Date*: 2014-01-28
    Sponsor Name:UNIVERSITY OF SASSARI
    Full Title: RANDOMIZED, CONTROLLED, MULTI-CENTER, INTERNATIONAL CLINICAL STUDY ON THE MOOD-STABILIZING EFFECTS OF MEMANTINE AS AN AUGMENTING AGENT vs. LAMOTRIGINE FOR ONGOING TREATMENT IN BIPOLAR-I DISORDER P...
    Medical condition: BIPOLAR I MOOD DISORDERS
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (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: 2021-004790-31 Sponsor Protocol Number: 55308942BIP2001 Start Date*: 2022-05-31
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Stratified, Double-blind, Placebo-Controlled Study to Investigate the Efficacy, Safety and Tolerability of JNJ-55308942 in Bipolar Depression
    Medical condition: Bipolar Depression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) PL (Completed)
    Trial results: View results
    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: 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: 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: 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: 2021-006861-39 Sponsor Protocol Number: GH001-BD-202 Start Date*: 2022-06-20
    Sponsor Name:GH Research Ireland Limited
    Full Title: A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode (GH001-BD-202)
    Medical condition: Bipolar II Disorder
    Disease: Version SOC Term Classification Code Term Level
    26.1 10037175 - Psychiatric disorders 10026753 Manic and bipolar mood disorders and disturbances HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-002093-34 Sponsor Protocol Number: NW-3509/020/III/2021 Start Date*: 2021-11-12
    Sponsor Name:NEWRON PHARMACEUTICALS SPA
    Full Title: A Phase II/III, multi-center, open-label, extension study to determine the long-term safety, tolerability, and efficacy of evenamide in patients with psychiatric disorders who participated in a pre...
    Medical condition: Patients with psychiatric disorders who participated in a previous trial with evenamide.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10037175 Psychiatric disorders SOC
    20.0 10037175 - Psychiatric disorders 10039626 Schizophrenia PT
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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: 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: 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: 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: 2012-004334-42 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: 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
    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
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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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