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Clinical trials for Bipolar II 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
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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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    19 result(s) found for: Bipolar II AND Mania AND Bipolar Disorder. Displaying page 1 of 1.
    EudraCT Number: 2015-000465-31 Sponsor Protocol Number: CannaBiD Start Date*: 2016-06-29
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: Cannabidiol in Bipolar Depression – CannaBiD-Study: An 8-week randomized, double-blind, placebo-controlled clinical trial of Cannabidiol as add-on therapy in bipolar depression
    Medical condition: Bipolar disorder, current episode depressed
    Disease: Version SOC Term Classification Code Term Level
    19.0 10037175 - Psychiatric disorders 10004936 Bipolar depression LLT
    19.0 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    19.0 10037175 - Psychiatric disorders 10026756 Manic depressive illness LLT
    19.0 10037175 - Psychiatric disorders 10026755 Manic depressive LLT
    19.0 10037175 - Psychiatric disorders 10004911 Bipolar affective disorder, depressed LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003803-31 Sponsor Protocol Number: PIO-BP Start Date*: 2015-05-29
    Sponsor Name:Hospital Universitario Araba (Sede Santiago)
    Full Title: Adjunct pioglitazone IN THE TREATMENT OF BIPOLAR DISORDER.
    Medical condition: Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004873 10004938 Bipolar disorders HLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004023-24 Sponsor Protocol Number: PRETEC-EPO Start Date*: 2016-12-15
    Sponsor Name:Copenhagen Affective Disorder research Center (CADIC), Psychiatric Centre Copenhagen, Rigshospitalet
    Full Title: Effect of erythropoietin (EPO) on cognitive function and frontal lobe activity in patients with bipolar disorder and unipolar depression in remission (PRETEC-EPO)
    Medical condition: Bipolar disorder and unipolar depression
    Disease: Version SOC Term Classification Code Term Level
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    21.1 10037175 - Psychiatric disorders 10045543 Unipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-000862-14 Sponsor Protocol Number: A-bipolar Start Date*: 2021-07-08
    Sponsor Name:Copenhagen Affective Disorder research Center (CADIC),
    Full Title: Effects of low dose Aspirin in bipolar disorder – a randomized controlled trial (the A-Bipolar RCT)
    Medical condition: Bipolar disorder
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10004935 Bipolar affective disorder, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001337-40 Sponsor Protocol Number: BXCL501-105 Start Date*: 2021-10-05
    Sponsor Name:BioXcel Therapeutics, Inc.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO DETERMINE EFFICACY AND SAFETY OF BXCL501 IN AGITATION ASSOCIATED WITH PEDIATRIC SCHIZOPHRENIA AND BIPOLAR DISORDER
    Medical condition: Subject that meets DSM-5 criteria for schizophrenia, schizoaffective, or schizophreniform disorder, or other specified/unspecified schizophrenia spectrum and/or other psychotic disorders OR Subjec...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10037175 - Psychiatric disorders 10039628 Schizophrenia and other psychotic disorders HLGT
    20.0 10037175 - Psychiatric disorders 10039629 Schizophrenia childhood LLT
    21.1 10037175 - Psychiatric disorders 10057667 Bipolar disorder PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2007-002551-17 Sponsor Protocol Number: 12022A Start Date*: 2007-12-14
    Sponsor Name:H. Lundbeck a/s
    Full Title: Randomised, double-blind, parallel-group, placebo-controlled, and active referenced study of Lu AA34893 to evaluate the efficacy and safety of three doses Lu AA34893 and quetiapine versus placebo i...
    Medical condition: Bipolar Depression at Phase II study with patients. Lu AA34893 is a novel compound under development by H. Lundbeck A/S as an antidepressant.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004936 Bipolar depression LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) AT (Prematurely Ended) FR (Completed) GB (Prematurely Ended) SE (Prematurely Ended) DE (Completed) LT (Prematurely Ended) SK (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: (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: 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: 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: 2005-004357-94 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: 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: 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: 2018-002749-12 Sponsor Protocol Number: ITI-007-402 Start Date*: 2019-01-18
    Sponsor Name:Intra-Cellular Therapies, Inc. (ITI)
    Full Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Adjunctive to Lithium or Valproate in the Treatment of Patients with Major D...
    Medical condition: Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004873 10004936 Bipolar depression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2006-001317-15 Sponsor Protocol Number: BAL2-2006 Start Date*: 2006-05-09
    Sponsor Name:University of Oxford
    Full Title: BALANCE 2: Bipolar disorder:Antidepressant/Lamotrigine/ANtipsychotic Comparative Evaluation
    Medical condition: Bipolar depression.
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005345-19 Sponsor Protocol Number: R076477BIM3003 Start Date*: 2006-05-25
    Sponsor Name:Janssen-Cilag International N.V.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone as Adjunctive Therapy to Mood S...
    Medical condition: Bipolar I Disorder
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002669-20 Sponsor Protocol Number: 03KET2018 Start Date*: 2018-09-18
    Sponsor Name:Celon Pharma SA
    Full Title: A multicentre, double-blind, randomised, placebo - controlled phase II study to assess efficacy, safety and pharmacokinetics of inhaled Esketamine in subjects with treatment-resistant bipolar depre...
    Medical condition: Eketamine, ketamine’s enantiomer, is designed for use in tretment resistant depression, both unipolar and bipolar. Many publications have demonstrated the effect of ketamine/esketamine (mainly admi...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002869-18 Sponsor Protocol Number: Start Date*: 2019-09-04
    Sponsor Name:Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
    Full Title: A randomised, double-blind, placebo controlled trial of pramipexole in addition to mood stabilisers for patients with treatment resistant bipolar depression.
    Medical condition: Bipolar disorder (BD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004873 10012386 Depression mental LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-004764-18 Sponsor Protocol Number: 01-17 Start Date*: 2017-07-24
    Sponsor Name:St Patrick’s Mental Health Services
    Full Title: Ketamine as an adjunctive therapy for Major Depression - a randomised controlled pilot trial: The KARMA-Dep Trial
    Medical condition: Depression
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (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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