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 Effective it is Over 1 Year

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03230097
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : July 11, 2018
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the efficacy, safety and tolerability of BI 409306 once daily compared to placebo given for 52 weeks to subjects with attenuated psychosis syndrome.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Drug: BI 409306 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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.
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : March 8, 2021
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BI 409306 Drug: BI 409306
twice daily

Placebo Comparator: Placebo Drug: Placebo
twice daily

Primary Outcome Measures :
  1. Time to first episode of psychosis [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) total score after 24 and 52 weeks of treatment [ Time Frame: Baseline, Week 24 and Week 52 ]
  2. Change from baseline in the BAC App composite T score after 52 weeks of treatment [ Time Frame: Baseline and Week 52 ]
  3. Change from baseline in Positive and Negative Syndrome Scale (PANSS) positive items score, negative items score, and total score after 52 weeks of treatment [ Time Frame: Baseline and Week 52 ]

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Ages Eligible for Study:   16 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Meet diagnostic criteria for attenuated psychosis syndrome as defined in DSM-5 and determined by SIPS administered at screening and diagnosis confirmed by NeuroCog Trials after review of video-taped SIPS interview.
  • North American Prodromal Longitudinal Study (NAPLS) risk calculator score ≥ 0.20 at screening.
  • Age ≥16 and ≤ 30 years at the time of consent/assent.
  • Male or female patients willing to use highly effective methods of contraception.

    • Female patients of childbearing potential 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 patient. 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.
  • 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 legislation. If the patient has a legal representative, then this legal representative must give written informed consent as well.

Exclusion criteria

  • Present or past diagnosis of schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder I, major depressive disorder with psychotic features, delusional disorder, brief psychotic disorder, other specified schizophrenia spectrum and other psychotic disorder (except attenuated psychosis syndrome), and unspecified schizophrenia spectrum and other psychotic disorder, according to DSM-5.
  • Patients taking antipsychotic medication for less than 8 weeks prior to informed consent.
  • Patients who begin taking an antipsychotic between Visit 1 and Visit 2.
  • Patients who have discontinued an antipsychotic medication less than two weeks prior to randomization.
  • Patients taking Clozapine.
  • Any suicidal behavior in the past 2 years (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
  • 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).
  • 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.
  • Known diseases of the central nervous system (including but not limited to any kind of seizures or stroke).
  • History of significant head injury (>5 minutes without consciousness).
  • 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.
  • 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.
  • Planned elective surgery requiring general anesthesia, or hospitalization for more than 1 day during the study period.
  • Significant history of drug or alcohol dependence or abuse (Substance Use Disorder as defined in DSM-5) within the last six months prior to informed consent/assent.
  • 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.
  • Patients taking strong or moderate CYP1A2 inhibitors who are also a CYP2C19 Poor Metabolizer (PM). Patients taking medication known to be a strong or moderate inhibitor 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.).
  • Patients taking strong or moderate CYP1A2 inhibitors who are also taking concomitant strong or moderate CYP2C19 inhibitors. (A list of CYP1A2 and CYP2C19 inhibitors can be found in the ISF.)
  • Patients with a history of moderate to severe hepatic impairment (Child-Pugh B / C).
  • Patients with a history of moderate to severe renal impairment (Stage 3 - 5).
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
  • In the judgment of the investigator, inability of the patient to comply with the clinical trial procedures.
  • Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational treatment(s).
  • Previous participation in any BI 409306 study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03230097

Contact: Boehringer Ingelheim Call Center 1-800-243-0127

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim Identifier: NCT03230097     History of Changes
Other Study ID Numbers: 1289.32
2016-004973-42 ( EudraCT Number )
1289-0032 ( Other Identifier: Company )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders