Purpose

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

Eligibility

Eligible Ages
Between 16 Years and 30 Years
Eligible Genders
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.
  • 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, or patients taking antipsychotic medication for a longer duration but who have not been on a stable dose for 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.
  • Suicidal behavior in the past 2 years reported in the Columbia Suicide Severity Rating Scale (C-SSRS) with a lethality of attempt ≥1, or with a lethality of 0 but a potential lethality of 2, or that in the judgement of the investigator would jeopardize the patient's safety while participating in the trial. The investigator/qualified rater must review all screening C-SSRS reports prior to randomization, documenting an additional interview assessing lethality of the behavior history when appropriate.
  • 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.
  • Meets criteria for Substance Use Disorder (DSM-5) within the 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.
  • Further exclusion criteria apply

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BI 409306
  • Drug: BI 409306
    twice daily
Placebo Comparator
Placebo
  • Drug: Placebo
    twice daily

Recruiting Locations

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Clinton Kilts
+001 (501) 526-8163
CDKilts@uams.edu

ProScience Research Group
Culver City, California 90230
Contact:
Marina Bussel
+001 (424) 227-8127
marina.bussel@prosciencerg.com

PRIME Clinic
New Haven, Connecticut 06519
Contact:
Scott Woods
+001 (203) 974-7038
scott.woods@yale.edu

University of Florida College of Medicine
Jacksonville, Florida 32209
Contact:
Steven Cuffe
+001 (904) 244-3990
steven.cuffe@jax.ufl.edu

Lifestream Behavioral Center
Leesburg, Florida 34748
Contact:
Thomas Valente
+001 (352) 315-7806
tjvalente@lsbc.net

Medical Research Group of Central Florida
Orange City, Florida 32763
Contact:
Adly Thebaud
+001 (386) 775-7627
athebaud@mrgcf.com

Augusta University
Augusta, Georgia 30912
Contact:
Joseph McEvoy
+001 (919) 819-9295
JMcEvoy@augusta.edu

Boston Medical Center
Boston, Massachusetts 02118
Contact:
David Henderson
+001 (617) 638-8141
dhenderson@bmc.org

Michigan Clinical Research Institute PC
Ann Arbor, Michigan 48105
Contact:
Rajaprabhakaran Rajarethinam
+001 (734) 834-8954
rpmmc@yahoo.com

University of Michigan Health System
Ann Arbor, Michigan 48109
Contact:
Stephan Taylor
+001 (734) 936-4955
sftaylor@med.umich.edu

Cherry Health
Grand Rapids, Michigan 49503
Contact:
Eric Achtyes
+001 (616) 965-8200
ericachtyes@cherryhealth.com

Precise Research Centers
Flowood, Mississippi 39232
Contact:
Joseph Kwentus
+001 (601) 420-5810
jkwentus@precise-research.com

PsychCare Consultants Research
Saint Louis, Missouri 63128
Contact:
Mohd Malik
+001 (314) 849-1853
azfar.malik@pccresearch.org

Altea Research Institute
Las Vegas, Nevada 89102
Contact:
Jelena Kunovac
+001 (602) 562-7000
kunovacmd@sbcglobal.net

University at Buffalo, The State University of New York
Buffalo, New York 14215
Contact:
Steven Dubovsky
+001 (716) 898-5940
dubovsky@buffalo.edu

New York State Psychiatric Institute
New York, New York 10032
Contact:
Joshua Kantrowitz
+001 (646) 774-6738
Kantrow@NYSpi.columbia.edu

Finger Lakes Clinical Research
Rochester, New York 14618
Contact:
Sarah Atkinson
+001 (585) 241-9670
sda@flclinical.com

The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
Contact:
Diana Perkins
+001 (919) 962-1401
diana_perkins@med.unc.edu

Duke University Medical Center
Durham, North Carolina 27705
Contact:
Richard Keefe
+001 (919) 684-4306
Richard.keefe@duke.edu

University of Cincinnati
Cincinnati, Ohio 45219
Contact:
Caleb Adler
+001 (513) 558-3362
ADLERCB@UCMAIL.UC.EDU

PeaceHealth Medical Group
Eugene, Oregon 97401
Contact:
Alireza Parsoei
+001 (458) 205-6444
aparsoei@peacehealth.org

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Christian Kohler
+001 (215) 614-0161
kohler@pennmedicine.upenn.edu

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Yasas Tanguturi
+001 (615) 936-3288
yasas.c.tanguturi@vanderbilt.edu

Community Clinical Research, Inc.
Austin, Texas 78754
Contact:
David Brown
+001 (512) 323-2622
david.brown@communityclinical.com

InSite Clinical Research
DeSoto, Texas 75115
Contact:
Rajinder Shiwach
+001 (972) 331-8748
rshiwach@aol.com

University Hills Clinical Research
Irving, Texas 75062
Contact:
Mary Ann Knesevich
+001 (972) 717-6262
maknesevich@aol.com

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Dawn Velligan
+001 (210) 567-5448
velligand@uthscsa.edu

Psychiatric and Behavioral Solutions, LLC
Salt Lake City, Utah 84105
Contact:
Frederick Reimherr
+001 (801) 467-1200
Fred.reimherr@hsc.utah.edu

University of Virginia Health System
Charlottesville, Virginia 22903
Contact:
Vishal Madaan
+001 (434) 243-3678
vm8d@virginia.edu

More Details

NCT ID
NCT03230097
Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

Boehringer Ingelheim Call Center
1-800-243-0127
clintriage.rdg@boehringer-ingelheim.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.