A randomised, controlled trial to investigate the effect of a four/six week intensified pharmacological treatment for schizophrenia, major depressive disorder and bipolar depression compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment.

Phase 1

• Conditions: Schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder or bipolar disorder type I and II (currently in a depressive episode); MedDRA version: 20.0Level: HLTClassification code: 10039620Term: Schizoaffective and schizophreniform disorders Class: 10037175; MedDRA version: 21.1Level: LLTClassification code: 10081270Term: Major depressive disorder Class: 10037175; MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873; MedDRA version: 21.1Level: LLTClassification code: 10004936Term: Bipolar depression Class: 10037175; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: CTIS2022-502185-24-00
• Lead Sponsor: niversity Medical Center Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1254

Inclusion Criteria

In- or out patients, at least 18 years of age up until 70., Being willing and able to provide written informed consent. If unable, having a legal guardian to provide written informed consent is allowed (participant’s opinion will also be considered in these cases)., Female subjects of child bearing potential must be willing to ensure that they use effective contraception during the trial and as per the requirements in the protocol (section 8.2)., Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features) or 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, 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., Subject has failed on current psychopharmacological treatment of current episode of SZ/MDD/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; more details in the protocol section 6.2) and subject needs to experience functional impairment.

Exclusion Criteria

Being pregnant or breastfeeding., Current active suicidal ideation within the last 2 weeks, defined as a score of 1 or higher on CDSS question 8, followed by an assessment by the treating clinician who determines it is not safe for the patient to participate in the study., Subject meets criteria for current alcohol and/or drugs substance use disorderdependency, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). For all study samples: Nnicotine 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 who are admitted in the (psychiatric) clinic due to a court or administrative order are not allowed to participate in the study., For the SZ sample only: schizophrenia subjects cannot meet the modified Andreasen criteria for remission., For the BD sample only: a score of 8 or higher on the Young Mania Rating Scale in order to exclude subjects with predominant manic symptoms or mixed symptoms., Subject has failed previously on the EIPT study medication (i.e. SZ: clozapine; MDD: esketamine intranasal/(es)ketamine IV *) or the TAU treatment for BD (quetiapine) due to inefficacy. Treatment duration as = 4 weeks within an efficacious dose range according to the SmPC., Subject has a known intolerance to clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only) or to all medication and excipients options for a study sample (related to the TAU treatment arms)., Meeting any of the contraindications of clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only *), or to all medication options for a study sample (related to the TAU treatment arms), as specified within the applicable SmPC., 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 psychotropic 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