A randomised, controlled trial to investigate the effect of a 6-week intensified pharmacological treatment for schizophrenia compared to treatment as usual in subjects who had a first-time treatment failure on their first-line treatment

niversity Medical Center Utrecht0 sites418 target enrollmentMarch 27, 2024

ConditionsSchizophrenia, schizoaffective disorder or schizophreniform disorder Mental and Behavioural Disorders

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Schizophrenia, schizoaffective disorder or schizophreniform disorder
Sponsor: niversity Medical Center Utrecht
Enrollment: 418
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 27, 2024

End Date

August 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity Medical Center Utrecht

Eligibility Criteria

Inclusion Criteria

•1\. In\- or out patients, at least 18 years of age up until 70 years
•2\. Being willing and able to provide written informed consent. If unable and allowed by local laws and regulations, having a legal guardian to provide written informed consent is allowed (subject’s opinion will also be considered in these cases).
•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 (section 8\.2 of protocol).
•4\. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM\-5\. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7\.0\.2\).
•5\. 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). \*
•6\. Subject has failed on current psychopharmacological treatment of current episode of SZ, as confirmed by a CGI\-I \=3\. \*\*
•7\. Subject and clinician intend to change pharmacotherapeutic treatment. \*\*\*
•8\. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment.
•8\.1\. The minimum symptom severity threshold is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5\.
•8\.2\. 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 clozapine due to inefficacy. Treatment duration as \=4 weeks within an efficacious dose range according to the SmPC.
•3\. Subject has a known intolerance to clozapine or to all TAU medication options.
•4\. Meeting any of the contraindications of clozapine or to all TAU medication options, as specified within the applicable SmPC. \*
•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 currently uses more than the allowed psychotropic concomitant medication and needs to stay on this medication during the study. \*\*
•7\. 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.
•8\. 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\) \*\*\*
•9\. 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.
•10\. Subjects who are admitted in the (psychiatric) clinic due to a court or administrative order are not allowed to participate in the study.