CTIS2023-506602-39-00
Recruiting
Phase 1
A randomised, controlled trial to investigate the effect of a six-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. - INTENSIFY SZ
niversitair Medisch Centrum Utrecht0 sites418 target enrollmentAugust 25, 2023
Conditionsschizophrenia, schizoaffective disorder, schizophrenifom disorderMedDRA version: 21.1Level: PTClassification code: 10039647Term: Schizophreniform disorder Class: 100000004873MedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873MedDRA version: 21.1Level: PTClassification code: 10039621Term: Schizoaffective disorder Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- schizophrenia, schizoaffective disorder, schizophrenifom disorder
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 418
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In\- or out patients, at least 18 years of age up until 70\., 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\)., 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\)., 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, as confirmed by a CGI\-I \=3\., Patient 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 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 \- 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 that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations., Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance., Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities., Subjects who meet the modified Andreasen criteria for remission., Subject has used clozapine in the past., Subject has a known intolerance to clozapine or to all TAU medication options., Meeting any of the contraindications of clozapine or to all TAU medication options, 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 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.
Outcomes
Primary Outcomes
Not specified
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