NCT06923891
Not yet recruiting
Phase 4
An Open-Label Study to Evaluate the Efficacy and Tolerability of Xanomeline/Trospium In First Episode/Early Phase Schizophrenia Patients
InterventionsXanomeline/Trospium
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Vanguard Research Group
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Medication Satisfaction Questionnaire (MSQ)
Overview
Brief Summary
This is an open label study of the treatment satisfaction, efficacy and tolerability of xanomeline/ trospium in a population of 172 participants diagnosed with schizophrenia in the early phase of illness. Participants will be followed for 24 weeks with scheduled assessments conducted by centralized raters, local mental health professionals and self-assessments completed by patients. Recruitment will be based on insufficient efficacy of previous antipsychotic or due to dissatisfaction with treatment as a result of unacceptable side effects on previous antipsychotic/patient choice, with approximately 50% for each enrollment criteria. Participants who present with both insufficient efficacy and unacceptable side effects will be considered as belonging to the insufficient efficacy subgroup. Treatment and assessments will be identical for the 2 groups. Primary outcome for participants enrolled will be improvement in overall treatment satisfaction as measured by the MSQ.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participant is aged 18-40 years, inclusive, at time of signing the ICF
- •Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.
- •Participant Scores MSQ ≤3 for the Medication Satisfaction Questionnaire (MSQ)
- •Within 5 years of first antipsychotic treatment for psychosis at time of signing ICF
- •Clinical reason to seek a change in antipsychotic treatment due to psychosis symptom severity, it is clinically appropriate for the participant to seek a change in antipsychotic treatment due to psychosis symptom severity, adverse effects, both, or overall patient judgement/choice.
- •Symptom Severity Criteria:
- •Clinical reasons include Positive and Negative Syndrome Scale (PANSS) total score of ≤ 120 at screening if participant is experiencing inefficacy from current antipsychotic treatment and
- •A score of ≥ 4 (moderate or greater) for ≥ 1 of the following PANSS Positive Subscale (P) items: i. Item 1 (P1; delusions), ii. Item 2 (P2; conceptual disorganization), iii. Item 3 (P3; hallucinatory behavior), iv. Item 6 (P6; suspiciousness/persecution) and
- •A Clinical Global Impressions-Severity scale (CGI-S) score of ≥ 4 at screening and baseline visits.
- •Adverse Event or Overall Patient Choice Criteria:
Exclusion Criteria
- •Any DSM-5 disorder other than schizophrenia within 6 months before screening (confirmed using MINI version 7.0.2 at screening) requiring clinical attention.
- •Active substance or alcohol abuse or dependence in the past 6 months (cannabis use is allowed if not fulfilling abuse criteria)
- •Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator)
- •Developmental disorder or intellectual disability
- •History of serious suicide attempt within the past 6 months
- •Risk of suicidal behavior as determined by the Investigator's clinical assessment. Lifetime history of clinically significant head trauma, or current history of other acute or serious medical condition or
- •History or presence of clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, gastrointestinal (\[GI\] e.g., obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\], endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
- •Active biliary disease (eg, symptomatic gallstones). Participants with other biliary histories are eligible and should be discussed with the medical monitor
- •History or high risk of urinary retention, gastric retention,
- •Untreated narrow-angle glaucoma
Arms & Interventions
Xanomeline/Trospium
Active Comparator
Cobenfy
Intervention: Xanomeline/Trospium (Drug)
Outcomes
Primary Outcomes
Medication Satisfaction Questionnaire (MSQ)
Time Frame: 12 weeks
Change in total MSQ from baseline to week 12
Secondary Outcomes
- Positive and Negative Syndrome Scale (PANSS)(12 weeks)
- Clinical Global Impression - Severity Scale (CGI-S)(12 weeks)
- All cause discontinuation(12 weeks)
- Personal and social performance scale (PSP)(12 weeks)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(12 weeks)
- Merck Adherence Estimator(12 weeks)
- Adverse Effects(12 weeks)
- Columbia Suicidal Severity Rating Scale (C-SSRS)(12 weeks)
Investigators
Study Sites (1)
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