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Compares treatment options for Schizophrenia and Related Disorders
Official title 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.
ClinicalTrials.gov ID: NCT05958875
What this study is testing
What is Clozapine?
Clozapine is an investigational medicine, given as an once-daily, being studied as a potential treatment for schizophrenia and related disorders.
Also referred to as ATC code: N05AH02.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Schizophrenia (SZ) affects approximately 4.5 million people across the European Union (EU) and is associated with annual healthcare and societal costs of 29 billion Euros. The impact on the daily life of patients is huge, ranging from frequent relapses and hospitalisations, the inability to maintain a job or continue scholing, to a low quality of life, impaired cognitive functioning, suicidal ideation and an increase morbidity rate, next to the large burden for carers 1.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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...
- Female people of child bearing potential must use effective contraception during the trial as per the requirements of the applicable SmPCs and should...
- Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-5. The...
- Subject experiences a treatment failure due to lack of how well it works in the current episode, as confirmed by a CGI-I ≥3; preferably this...
You likely can't join if
- Being pregnant or breastfeeding.
- 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...
- Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the people at risk because of...
See the full eligibility 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 people 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...
- 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...
- Subject experiences a treatment failure due to lack of how well it works in the current episode, as confirmed by a CGI-I ≥3; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5...
- 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 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).
- Being pregnant or breastfeeding.
- 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 experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the people at risk because of participation in the trial, or may influence the result of the trial...
- people 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...
- 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...
- people have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- people who meet the modified Andreasen criteria for remission.
- people that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations.
- people dependent on the sponsor, investigator or trial site must be excluded from participation in advance
The study team makes the final eligibility decision.
Where it's taking place
- Innsbruck, Austria
- Augsburg, Germany
- Bielefeld, Germany
- Dortmund, Germany
- Frankfurt am Main, Germany
- Mainz, Germany
- Münster, Germany
- Brescia, Italy
- Cagliari, Italy
- Naples, Italy
- Turin, Italy
- Barcelona, Spain
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Innsbruck, Austria; Augsburg, Germany; Bielefeld, Germany; Dortmund, Germany; Frankfurt am Main, Germany; Mainz, Germany and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.