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.

Launched by DR. INGE WINTER · Jul 25, 2023

Keywords

ClinConnect Summary

The INTENSIFY trial is studying how a more intense six-week treatment approach for bipolar depression compares to the standard treatment for people who haven't had success with their first medication. Bipolar disorder causes extreme mood changes, and many people with this condition struggle more with depression than with manic episodes. This trial aims to find out if starting additional antidepressant medications earlier can help those who have not responded well to their initial treatment. The goal is to improve treatment options for patients and create a more personalized approach to managing bipolar disorder.

To participate in this trial, you need to be at least 18 years old and currently experiencing your first treatment failure with a first-line medication for bipolar depression. You will also need to have moderate symptoms that are affecting your daily life. Participants can expect to receive an intensified treatment plan, and throughout the study, they will be closely monitored to assess their progress. If you're interested in joining, it's important to discuss this with your healthcare provider to see if you meet the eligibility criteria and to understand what participation would involve.

Gender

ALL

Eligibility 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 his/her first treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; 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).
• • 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 failed previously on quetiapine due to inefficacy (after treatment duration of ≥ 4 weeks within an efficacious dose range according to the SmPC.
• • 3. Subject has a known intolerance to quetiapine or to all EIPT medication or to all TAU medication.
• • 4. 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.
• • 5. 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.
• • 6. 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.
• • 7. 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.
• • 8. 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.
• • 9. Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
• • 10. 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.
• • 11. Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
• • 12. Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1).
• • 13. 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).