Clinical trial of BI 425809 effect on cognition and functional capacity inschizophrenia.
- Conditions
- schizophreniaMedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-003760-11-IT
- Lead Sponsor
- BOEHRINGER-INGELHEIM ITALIA S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 586
1. Patients must be capable of providing signed and dated written
informed consent by date of Visit 1 in accordance with ICH Harmonized
Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local
legislation prior to the admission to the trial.
2. Male or female patients who are 18-50 years (inclusive) of age at time
of consent.
3. Diagnosis of schizophrenia utilizing DSM-5 with the following clinical
features:
-- Outpatient, clinically stable and in the residual (non-acute) phase of
their illness.
-- No hospitalization or increase in level of psychiatric care due to
worsening of schizophrenia within 12 weeks prior to randomization.
-- PANSS score: items P1, P3-P6 <= 5 and item P2 and P7 <= 4 at Visit 1,
and confirmed at Visit 2.
4. Patients should have functional impairment in day-to-day activities
such as difficulties following conversation or expressing themselves,
difficulties to stay focused, difficulties to remember instructions, what to
say or how to get to places, per investigator judgement.
5. Patients maintained on current antipsychotic treatment (minimum 1
and maximum 2 antipsychotics, but clozapine is not allowed) for at least
12 weeks and on current dose for at least 35 days prior to
randomization.
-- Doses should be within the recommended dose range listed in the
approved product labelling of the country where the study is being
conducted.
-- Switch from 1-month to 3-monthinjectable formulation of same
antipsychotic during the 12 weeks prior to randomization is allowed, but
not with in last 35 days prior to randomization.
-- Note: If the total dose is stable, different dosage forms of the same
antipsychotic treatment will be considered as one antipsychotic.
6. Patients with any other concomitant psychoactive medications (except
for anticholinergics) need to be maintained on same drug for at least 12
weeks and on current dose/ regimen for at least 35 days prior to
randomization.
-- Maximum daily benzodiazepine load of up to 1 mg lorazepamequivalent
and
hypnotic load up to 0.25 mg brotizolam-equivalent as needed (pro re
nata, prn). Table of relevant medications and their equivalencies will be
provided as a part of ISF
-- For any other psychoactive medications, doses should be within the
recommended dose range listed in the approved product labelling of the
country where the study is being conducted.
Further criteria apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 586
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Participant with current DSM-5 diagnosis other than Schizophrenia,
including but not limited to bipolar, schizoaffective, major depressive
disorder etc. M.I.N.I. for Psychotic disorders should be used for
guidance.
2. Cognitive impairment due to developmental, neurological (e.g.,
epilepsy, stroke) or other disorders including head trauma, or patients
with dementia.
3. Severe movement disorders
-- Leading to cognitive impairment (e.g. Parkinson dementia), or
-- Interfering with the efficacy assessments, or
-- Due to antipsychotic treatment that cannot be controlled with low
dose anticholinergic treatment (equal to maximum 1 mg benztropine
twice daily). Table of relevant medications and their equivalencies will
be provided as a part of ISF
4. Any suicidal behavior in the past 1-year prior to screening and during
the screening period.
5. Suicidal ideation of type 5 in the C-SSRS (i.e. active suicidal thought
with plan and intent)
in the past 3 months prior to screening and up to and including Visit 2.
-- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active
suicidal thought with intent but without specific plan), within 3 months
prior to screening and up to and including Visit 2, can be randomized in
the study, if assessed and documented by a licensed mental health
professional that there is no immediate risk of suicide.
6. History of moderate or severe substance use disorder (other than
caffeine and nicotine), as defined in DSM-5 within the last 12 months
prior to informed consent.
7. Positive urine drug screen at Visit 1 based on central lab test. For a
list of drugs assessed in the urine drug screen
8. Patients who were treated with any of the following within 6 months
prior to randomization:
-- Clozapine
-- Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil)
-- Ketamine
-- Electroconvulsive therapy (ECT) or Modified ECT
Further criteria apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method