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Clinical trials for Seroquel AND Bipolar 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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
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    8 result(s) found for: Seroquel AND Bipolar AND Mania. Displaying page 1 of 1.
    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: 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: 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: 2009-011253-40 Sponsor Protocol Number: PQ2 Start Date*: 2009-04-23
    Sponsor Name:AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
    Full Title: Paroxetine or Quetiapine in Addition to Mood Stabilizers in Bipolar Depression
    Medical condition: Major Depressive Episode in Bipolar Disorder
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004908 Bipolar affective disorder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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: 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: 2004-000113-18 Sponsor Protocol Number: CLIC477D2302 Start Date*: 2004-09-23
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety and tolerability of licarbazepine 750-2500 mg/d combined with risperidone in the treatment of mani...
    Medical condition: Bipolar I disorder, manic and mixed episodes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Completed) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-000211-99 Sponsor Protocol Number: D1449L00010 Start Date*: 2005-04-12
    Sponsor Name:AstraZeneca A/S
    Full Title: Acutely Manic Patients Insufficiently Responding After 2 Weeks Continued Quetiapine Monotherapy: Continued Quetiapine Versus Sodium Valproate Add-on.
    Medical condition: Bipolar affective disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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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