EUCTR2016-004973-42-GB进行中（未招募）1 期
A phase II randomised, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of orally administered BI 409306 during a 52-week treatment period as an early intervention in patients with attenuated psychosis syndrome.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •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
排除标准
- •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
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