Could a quicker switch to stronger meds beat bipolar depression?
NCT ID NCT05973786
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether quickly switching to a more intensive combination of medications helps people with bipolar depression who didn't get better on their first treatment. About 418 adults will either receive standard care or an intensified regimen of antidepressants and mood stabilizers for six weeks. The goal is to see if this approach leads to greater improvement in depression symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of antidepressants (escitalopram, sertraline, venlafaxine, bupropion) and mood stabilizers (lithium, valproate, quetiapine)
- What this could lead to
- If successful, this could provide a clear treatment strategy for people with bipolar depression who don't respond to their first medication, potentially reducing suffering and improving daily life.
- What could go wrong
- This is a phase 3 trial, but it's still testing a strategy rather than a new drug. The benefits may be modest, and some participants may experience side effects from the medications. Results may not apply to everyone with bipolar depression.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 418 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. In- or out patients, at least 18 years of age. 2. Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure. 3. Female subjects of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should have a negative pregnancy test at visit 1 or 2 (before randomisation). Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial (see section 8.2.1). 4. Meeting diagnostic criteria for a primary diagnosis of bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). 5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably, this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well. 6. Subject and clinician intend to change pharmacotherapeutic treatment. 7. A minimum symptom severity threshold needs to be present (moderate leve) and subject needs to experience functional impairment. * The minimum symptom severity threshold is a score of ≥20 on the Montgomery Åsberg Depression Rating Scale (MADRS) * Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS). Exclusion criteria 1. Being pregnant or breastfeeding. 2. Subject has a known intolerance to quetiapine or to all EIPT medication or to all TAU medication. 3. Meeting any of the contraindications for quetiapine, or to all EIPT medication or to all TAU medication options, as specified within the applicable SmPC, supported by clinically significant abnormal values on local laboratory tests, electrocardiogram (ECG) or physical examinations. 4. Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1. 5. Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial. 6. Subjects with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study. 7. Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed. 8. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities. 9. A score of 12 or higher on the Young Mania Rating Scale (YMRS) in order to exclude subjects with predominant manic symptoms or mixed symptoms. 10. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance. 11. Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1). 12. Subjects with a history of antidepressant-induced mania or hypomania or recent rapid cycling (based on the medical file of the potential participant or the clinical judgment of the clinician).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino"
RECRUITINGTurin, Italy
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Eginition hospital, department of psychiatry
NOT_YET_RECRUITINGAthens, 11528, Greece
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Fundació Clínic per a la Recerca Biomèdica
RECRUITINGBarcelona, Spain
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King's College London, Psychiatry & Cognitive Neuroscience
NOT_YET_RECRUITINGLondon, SE5 8AF, United Kingdom
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Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz
RECRUITINGMainz, Germany
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LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft
RECRUITINGDortmund, 44287, Germany
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Medical University Innsbruck
RECRUITINGInnsbruck, Austria
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Universita degli Studi di Brescia
RECRUITINGBrescia, Italy
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University Hospital Frankfurt am Main - Goethe University
RECRUITINGFrankfurt am Main, Germany
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University of Cagliari
RECRUITINGCagliari, Italy
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Università degli studi della Campania Luigi Vanvitelli
RECRUITINGNaples, 80138, Italy
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Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld
RECRUITINGBielefeld, Germany
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Westfälische Wilhelms-Universität Münster
RECRUITINGMünster, Germany
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