Intensified treatment for bipolar depression after first treatment failure
A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.
PHASE3 · UMC Utrecht · NCT05973786
This study is testing a stronger six-week medication plan for people with bipolar depression who didn't get better with their first treatment to see if it works better than the usual approach.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 418 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht (other) |
| Locations | 13 sites (Innsbruck and 12 other locations) |
| Trial ID | NCT05973786 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a six-week intensified pharmacological treatment for patients with bipolar depression who have experienced a first-time treatment failure on their first-line treatment. The study compares this intensified approach using medications like Escitalopram, Sertraline, Venlafaxine, Lithium, and Valproate acid to standard treatment as usual. Participants will be assessed for their bipolar depression diagnosis and treatment response, with the aim of identifying more effective treatment strategies for this challenging condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of bipolar depression who have experienced a first treatment failure.
Not a fit: Patients who are not currently experiencing a depressive episode or those who have not had a first treatment failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from bipolar depression who have not responded to initial therapies.
How similar studies have performed: Other studies have shown promise in using intensified pharmacological approaches for treatment-resistant bipolar depression, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Innsbruck and 12 other locations
- Medical University Innsbruck — Innsbruck, Austria (RECRUITING)
- Universitätsklinik für Psychiatrie und Psychotherapie Bielefeld — Bielefeld, Germany (RECRUITING)
- LWL-Klinik Dortmund, Bereich Forschung & Wissenschaft — Dortmund, Germany (RECRUITING)
- University Hospital Frankfurt am Main - Goethe University — Frankfurt am Main, Germany (RECRUITING)
- Klinik für Psychiatrie und Psychotherapie der Universitätsmedizin Mainz — Mainz, Germany (RECRUITING)
- Westfälische Wilhelms-Universität Münster — Münster, Germany (RECRUITING)
- Eginition hospital, department of psychiatry — Athens, Greece (NOT_YET_RECRUITING)
- Universita degli Studi di Brescia — Brescia, Italy (RECRUITING)
- University of Cagliari — Cagliari, Italy (RECRUITING)
- Università degli studi della Campania Luigi Vanvitelli — Naples, Italy (RECRUITING)
- Azienda Ospedaliero-Universitaria "Città della Salute e della Scienza di Torino" — Turin, Italy (RECRUITING)
- Fundació Clínic per a la Recerca Biomèdica — Barcelona, Spain (RECRUITING)
- King's College London, Psychiatry & Cognitive Neuroscience — London, United Kingdom (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Inge Winter, Dr.
- Email: i.winter@umcutrecht.nl
- Phone: +31875553227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bipolar Depression