2023-506602-39-00
Recruiting
Phase 4
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.
Universitair Medisch Centrum Utrecht12 sites in 4 countries310 target enrollmentStarted: December 20, 2023Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Universitair Medisch Centrum Utrecht
- Enrollment
- 310
- Locations
- 12
- Primary Endpoint
- Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
Overview
Brief Summary
The primary objective is to compare the treatment response (baseline; visit 2 vs. end of treatment; visit 4), expressed as in symptom severity at six weeks and changes in symptom severity from baseline as measured through the Positive And Negative Syndrome Scale (PANSS) under an early-intensified pharmacological treatment to that under treatment as usual, in subjects who had a first-time treatment failure on their first-line treatment for schizophrenia, schizoaffective or schizophreniform disorder.
Study Design
- Allocation
- Randomized
- Primary Purpose
- Randomisation during the entire study
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •In- or out patients, at least 18 years of age up until
- •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 or 2 (before; randomisation; section 8.2).
- •Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder, according to DSM-
- •The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
- •Subject experiences his/her first treatment failure due to lack of efficacy in the current episode, as confirmed by 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.
- •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.
- •Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit
- •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.
- •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
- •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.
- •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.
Outcomes
Primary Outcomes
Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
Mean change from baseline (visit 2) in symptom severity as measured by the PANSS total score at six weeks (visit 4) will be compared between the two treatment arms (EIPT vs. TAU. )
Secondary Outcomes
- Change from baseline (visit 2) in PANSS subscale scores (positive, negative and general) at visit 4; EIPT vs TAU.
- 2.a. Change from baseline (visit 2) in the severity sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU. 2.b. Improvement sub-score of the Clinical Global Impression Scale (CGI 1) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) in total Hospital Anxiety and Depression Scale (HADS) total score and anxiety and depression subscales at visit 4; EIPT vs TAU.
- Change from baseline (visit 2) in quality of life and functioning measures (Q-LES-Q-SF, LAPS, QLS-100 and SDS) at visit 4; EIPT vs TAU.
- Changes from baseline (visit 2) on Trail Making Test, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test as well as the Perceived Deficits Questionnaire at visit 4; EIPT vs TAU.
- Presence of symptomatic remission at visit 4; EIPT vs TAU. Remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content.
- Presence of reported adverse events (related and unrelated to treatment) as measured through General Assessment of Side Effects Scale (GASE) and reported spontaneously througout the study; EIPT vs TAU.
- Concomitant medication use throughout the study; EIPT vs TAU.
- Premature treatment discontinuation before visit 4 and time to treatment discontinuation and reported reason of discontinuation; EIPT vs TAU.
- Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU.
Investigators
Dr. Inge Winter
Scientific
Universitair Medisch Centrum Utrecht
Study Sites (12)
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