This study tests whether BI 409306 prevents patients with a specific type of mental illness (attenuated psychosis syndrome) from becoming worse. This study looks at how well patients tolerate the medicine and how safe and effective it is over 1 year.
- Conditions
- attenuated psychosis syndromeMedDRA version: 20.0 Level: LLT Classification code 10037234 Term: Psychosis System Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2016-004973-42-GB
- Lead Sponsor
- Boehringer Ingelheim Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 300
1. Meet diagnostic criteria for attenuated psychosis syndrome as defined in DSM-5 and determined by SIPS administered at screening, and diagnosis confirmed by Central Rating Committee after review of video-taped SIPS interview.
2. Inclusion criterion 2 removed in global amendment 3. Numbering of subsquent criteria not changed.
3.Age =16 and = 30 years at the time of consent/assent.
4. Male or female patients willing to use highly effective methods of contraception.
- Female patients of childbearing potential1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. Patients must agree to use birth control throughout the trial and for at least 28 days after treatment has ended. Acceptable methods of birth control include combined estrogen-progestin oral, intravaginal or transdermal contraceptives, progestogen-only oral, injectable or implantable contraceptives, intrauterine devices (IUDs), intrauterine hormone releasing systems (IUSs), bilateral tubal occlusion, vasectomized sexual partner, and complete sexual abstinence (if acceptable by local health authorities) is allowed when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Male patients who are able to father a child must be ready and able to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
5. Signed and dated written informed consent in accordance with Good Clinical
Practice (GCP) and local legislation prior to any study-related procedures OR
signed and dated informed consent provided by the patient’s parent(s) (or legal
guardian) and assent by the patient prior to any study-related procedures in
accordance with GCP and local legislation2. If the patient has a legal
representative, then this legal representative must give written informed consent
as well.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Present or past diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder I, or major depressive disorder with psychotic symptoms according to DSM-5.
2. Patients taking antipsychotic medication for less than 8 weeks, or patients taking antipsychotic medication for a longer duration but who have not been on a stable dose fro 8 weeks prior to informed consent.
3. Patients who begin taking an antipsychotic between Visit 1 and Visit 2.
4. Patients who have discontinued an antipsychotic medication less than two weeks prior to randomization.
5. Patients taking Clozapine.
6. Suicidal behavior in the past 2 years reported in the Columbia Suicide Severity Rating sacele ( C-SSRS) with a lethality of attempt of =1 , or with a lethality of 0 but a potential lethality of 2, or that in the judgement of the investigator would jeopardise the patient's safety while participating in the trial. The investigator/qualified rater must review all screening C-SSRS reports prior to randomisation, documenting an additional interivew asessing lethality of the behaviour history when appropriate.
7. Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent).
8. In the judgment of the investigator, any clinically significant finding from the physical examination or laboratory value deviating from normal or any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize a patient’s safety while participating in the clinical trial.
9. Known diseases of the central nervous system (including but not limited to any kind of seizures or stroke).
10. History of significant head injury (>5minute without consciousness).
11. A serious developmental disorder that in the judgement of the investigator would inhibit the patient's ability to comply with all study procedures, or mental retardation (documented IQ <70), or acute attenuated symptoms exclusively related to intoxication from a psychotropic substance.
12. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix.
13. Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
14. Meets criteria for Substance Use Disorder (DSM-5) within the six months prior to informed consent/assent.
15. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
16. Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be strong or moderate inhibitors of CYP1A2 must be prospectively genotyped to ensure they are not poor metabolizers of CYP2C19. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.).
17. Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CY
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to investigate the efficacy, safety and tolerability of BI 409306 compared to placebo given for 52 weeks to patients with attenuated psychosis syndrome. The study is designed to show superiority of BI 409306 over placebo in achieving remission of APS as well as improvement in cognition and functional capacity.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is time to remission from APS within a 52 week timeframe. Remission from APS is defined as a score of <3 on all the P1-P5 Positive Symptom items of the SOPS and maintained until the end of treatment. ;<br> Timepoint(s) of evaluation of this end point: 1: 52 weeks<br>
- Secondary Outcome Measures
Name Time Method