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.

Phase 1

• Conditions: Bipolar depression; MedDRA version: 21.1Level: LLTClassification code: 10004936Term: Bipolar depression Class: 10037175; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2023-506605-19-00
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

In- or out patients, at least 18 years of age., 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., 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 (section 8.2.1). Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial (see section 8.2.1)., 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)., Subject currently experiences his/her first treatment failure due to lack of efficacy; this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within the dose range as specified in the Summary of Product Characteristics (SmPCs)., Subject has failed on current psychopharmacological treatment of current episode of BD, as confirmed by a CGI-I =3., Subject and clinician intend to change pharmacotherapeutic treatment., A minimum symptom severity threshold needs to be present (moderate level; see below) 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

Being pregnant or breastfeeding., Moderate or high suicidal ideation within the last 2 weeks, defined as a score of 9 or higher on Module B (Suicidality) of the Mini International Neuropsychiatric Interview (MINI v7.0.2), 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 alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Moderate and severe alcohol and/or cannabis use disorder are not allowed., Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance., Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1)., 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)., Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities., 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., Subject has failed previously on quetiapine due to inefficacy (after treatment duration of = 4 weeks within an efficacious dose range according to the SmPC)., Subject has a known intolerance to quetiapine or to all EIPT medication or to all TAU medication., 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., 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., Subject currently uses more than the allowed concomitant medication and needs to stay on this medication during the study., Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified