SchizophreniaPhase 2NCT02281773
A Study to Investigate the Efficacy, Safety and Tolerability of Four Different Doses of BI 409306 Compared to Placebo Given for 12 Weeks in Patients With Schizophrenia on Stable Antipsychotic Treatment.
A Phase 2 study testing BI 409306 100 mg QD, BI 498306 50 mg QD and BI 498306 25 mg QD in people with Schizophrenia, run by Boehringer Ingelheim at 43 sites in 5 countries.
Trial summary
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- BI 409306 100 mg QD, BI 498306 50 mg QD and BI 498306 25 mg QD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 10 Nov 2014to 13 Jun 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) with the following clinical features:
- Clinically stable and are in the residual (non-acute) phase of their illness for at least 8 weeks b) Current antipsychotic and concomitant psychotropic medications must meet the criteria below: b)-1 Maintained on current atypical (second generation) antipsychotic medications (in any approved dosage form) other than Clozapine and on current dose for at least 8 weeks prior to randomisation, and/or b)-2 Maintained on current typical (first generation) antipsychotic medications and on current dose for at least 6 months, optionally combined with anticholinergics if treated with a stable dose for at least 6 months prior to randomisation, and/or b)-3 Maintained on current concomitant psychotropic medications other than anticholinergics, antiepileptics and lithium, and on current dose for at least 8 weeks prior to randomisation. Antiepileptics and lithium are allowed if initiated at least 6 months prior to randomisation.
- b)-4 Anticholinergics, antiepileptics and lithium have been washed out for at least 6 months prior to randomisation if the treatments that patients were using before entering the clinical trial are discontinued.
- Have no more than a "moderate" severity rating on hallucinations and delusions (Positive and Negative Syndrome Scale (PANSS)-positive syndrome Hallucinatory Behavior item score < =4 and Delusions item score < = 4) d) Have no more than a "moderate" severity rating on positive formal thought disorder (PANSS-positive syndrome Conceptual Disorganization item score < = 4) e) Have a minimal level of extrapyramidal symptoms (Simpson-Angus Scale total score < 6) and depressive symptoms (PANSS-general psychopathology syndrome Depression item score < = 4)
- Male or female patients age 18 to 55 years
- Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures,in the investigator's opinion.
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- Signed and dated written informed consent by date of Visit 1 in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.
- Patients must have an identified informant who will be consistent throughout the study. The informant must interact with the subject at least 2 times a week.
- Note: Informant ratings are needed for SCoRS global ratings at Randomisation Visit (Visit 2) and (early) End of Treatment Visit. In person informant ratings on the study visits are preferred whenever possible. However, if the informant is not available for in person ratings, telephone interview is acceptable. The informant must be available for a telephone interview at Visit 2 and (e)EOT Visit.
Who cannot join
- Patient treated with more than two antipsychotic medications (including more than two dosage forms)
- Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator
- 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 Suicidal Severity Rating Scale (C-SSRS) 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 of the medical examination (including BP, PR and ECG) 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
- History or diagnosis of symptomatic and unstable/uncontrolled gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hematological or hormonal disorders
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- For female patients:
- Pre-menopausal women (last menstruation < =1 year prior to informed consent) who:
- are nursing or pregnant or
- are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the trial until 28 days after the last treatment administration, and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, vasectomized partner, transdermal patch, intra uterine devices/systems (IUDs/IUSs), combined estrogen-progestin oral contraceptives as well as implantable or injectable hormonal contraceptives. 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. Double barrier methods are permissible (if acceptable by local health authorities, note that this is not an acceptable method in EU countries).
- For male patients:
- Men who are able to father a child, unwilling to be abstinent or use adequate contraception for the duration of study participation and for at least 28 days after treatment has ended.
- Known history of HIV infection
- Diseases of the central nervous system (including but not limited to any kind of seizures, stroke or any psychiatric disorders other than schizophrenia)
- Any subject who on the Mini-international neuropsychiatric Interview (M.I.N.I.) has a categorical diagnosis of another current major psychiatric disorder.
- History of malignancy within the last 5 years, except for basal cell carcinoma
- Planned elective surgery requiring general anaesthesia, or hospitalisation for more than 1 day during the study period
- Significant history of drug dependence or abuse (including alcohol, as defined in DSM-5-substance use disorder or in the opinion of the investigator) within the last two years prior to informed consent, or a positive urine drug screen for cocaine, opioid, PCP, amphetamine, heroin, or marijuana at screening
- Patient needs to take long-acting hypnotics and anxiolytics (i.e. Diazepam)
- Patients taking medications that are known to be strong or moderate CYP3A4 inhibitors
- Participation in another trial with an investigational drug or procedure within 30 days or 6 half-lives (whichever is longer) or participation in another trial with any cognitive-enhancing therapy or procedure within 90 days prior to screening
- Previous participation in any BI 409306 study
- Not fluent in the language of the batteries/questionnaires which will be used in the country
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States24 sites
Atlanta Center
Atlanta, Georgia, 30331
Community Clinical Research, Inc.
Austin, Texas, 78754
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Comprehensive Clinical Development, Inc.
Cerritos, California, 90703
Northwestern University
Chicago, Illinois, 60611
Uptown Research Institute
Chicago, Illinois, 60640
InSite Clinical Research
DeSoto, Texas, 75115
Collaborative Neuroscience Network
Garden Grove, California, 92845
Lake Charles Clinical Trials LLC
Lake Charles, Louisiana, 70629
Innovative Clinical Research
Lauderhill, Florida, 33319
K and S Professional Research Services, LLC
Little Rock, Arkansas, 72201
Pacific Institute of Medical Research
Los Angeles, California, 90024
Florida Clinical Research Center
Maitland, Florida, 32751
SRSD, Inc. dba Synergy San Diego
National City, California, 91950
Behavioral Clinical Research, Inc.
North Miami, Florida, 33161
NRC Research Institute
Orange, California, 92868
Finger Lakes Research
Rochester, New York, 14618
University of Rochester Medical Center
Rochester, New York, 14623
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103
Mid-America Clinical Research, LLC
St Louis, Missouri, 63109
St. Louis Clinical Trials
St Louis, Missouri, 63141
Richmond Behavioral Associates
Staten Island, New York, 10312
Collaborative Neuroscience Network
Torrance, California, 90502
Comprehensive Clinical Development
Washington D.C., District of Columbia, 20016
Japan10 sites
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Kobe University Hospital
Hyogo, Kobe, 650-0017
Nara Medical University Hospital
Nara, Kashihara, 634-8522
Kansai Med. Univ. Med. Ctr., Osaka, Neuropsychiatry
Osaka, Moriguchi-city, 570-8507
Hizen Psychiatric Center, Saga, PSY
Saga, Kanzaki-gun, 842-0192
Iwaki Clinic, Tokushima, Psychosomatic Medicine
Tokushima, Anan, 774-0014
National Center Neurology and Psychiatry
Tokyo, Kodaira, 187-8851
Showa University Karasuyama Hospital
Tokyo, Setagaya, 157-8577
Showa University East Hospital
Tokyo, Shinagawa, 142-0054
Taiwan4 sites
Chang-Hua Christian Hospital
Changhua, 500
Kai-Syuan Psychiatric Hospital
Kaohsiung City, 802
NCKUH
Tainan, 704
Taipei City Hospital
Taipei, 110
Germany3 sites
Universitätsklinikum Köln (AöR)
Cologne, 50937
LVR-Klinikum Düsseldorf
Düsseldorf, 40629
Uniklinikum Heidelberg
Heidelberg, 69115
Canada2 sites
Depression, Mood Disorders and Schizophrenia Treatment Centr
Burlington, Ontario, L7R4E2
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, V2A 4M4
About this study
Official title: A Phase II Randomised, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period in Patients With Schizophrenia on Stable Antipsychotic Treatment
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
- Conditions
- Schizophrenia
- Being tested
- BI 409306 100 mg QD, BI 498306 50 mg QD, Placebo, BI 498306 25 mg QD, BI 409306 10 mg QD
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 409306 100 mg QDDrug
BI 498306 50 mg QDDrug
PlaceboDrug
BI 498306 25 mg QDDrug
BI 409306 10 mg QDDrug
| Study group | Role | What they receive |
|---|---|---|
| dose 1 | Experimental | Not described Receives: Drug: BI 409306 10 mg QD |
| dose 2 | Experimental | Not described Receives: Drug: BI 498306 25 mg QD |
| dose 3 | Experimental | Not described Receives: Drug: BI 498306 50 mg QD |
| dose 4 | Experimental | Not described Receives: Drug: BI 409306 100 mg QD |
| placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.
Measured: Baseline and Week 12
Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)
Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).
Measured: Up to 20 weeks
Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)
Occurrence of Protocol-specified adverse events of special interest (AESI).
Measured: Up to 20 weeks
Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)
Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Measured: Baseline, Week 6 and Week 12
Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)
C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition.
Measured: Up to 12 weeks
Secondary outcomes (5)
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment
Change from baseline in everyday functional capacity as measured by Schizophrenia Cognition Rating Scale (SCoRS) global ratings after 12 weeks of treatment. SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functions. Each item was rated on a 4-point scale. Higher ratings reflected a greater degree of impairment. The SCoRS global total scores is the sum of the 20 items and it varies from 20 to 80 with 20 being the best outcome and 80 being the worst. If any individual item was missing, it was imputed with the average of that patient's non missing responses. If >5 items were missing, the total score was missing.
Measured: Baseline and Week 12
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale score after 12 weeks of treatment. The CGI-S is a one-item evaluation completed by the clinician on the patient's severity of psychopathology. The CGI-S was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Measured: Baseline and Week 12
Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment
Patient Global Impressions-Improvement (PGI-I) scale score measured after 12 weeks of treatment. The PGI of improvement is a simple evaluation completed by the patient to assess the patient's overall evaluation of his/her status. The PGI of improvement was rated ordinally from one to 7. Higher scores indicate more severe symptoms.
Measured: Up to 12 weeks
Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom)
Change from baseline in PANSS negative symptom factor score after 12 weeks of treatment (for subset of patients diagnosed with negative symptom). This outcome measure was not analysed due to low number of patients in the PANSS negative symptom subgroup. The PANSS negative symptom scale has 7 items. Each was rated from one to 7 points. The total factor score was the summation of the 7 points for each item, leading the total score ranging from 7 to 49.
Measured: Baseline and Week 12
Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
Change in psychopathology symptoms as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Measured: Baseline, Week 6 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study start10 Nov 2014
- Primary completion26 May 2016
- Study completion13 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 518 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02281773
- Sponsor's protocol ID
- 1289.6
- Other IDs
- 2013-005015-28
- Status last verified
- Sep 2017
- First submitted
- 31 Oct 2014
- Last updated
- 19 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Dorner-Ciossek C, Kroker KS, Rosenbrock H. Role of PDE9 in Cognition. Adv Neurobiol. 2017;17:231-254. doi: 10.1007/978-3-319-58811-7_9.
PubMed 28956335Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
PubMed 28433500
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Four Orally Administrated Doses of BI 409306 During a 12-week Treatment Period in Patients With Schizophrenia on Stable Antipsychotic Treatment
- ClinicalTrials.gov ID
- NCT02281773
- Acronym / sponsor ID
- 1289.6
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 518 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2014 (actual)
- Primary completion
- 26 May 2016 (actual)
- Study completion
- 13 Jun 2016 (actual)
- First posted
- 4 Nov 2014 (estimated)
- Results
- Posted 19 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to investigate the efficacy, safety and tolerability of four different doses of BI 409306 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| dose 1 | Experimental | Drug: BI 409306 10 mg QD |
| dose 2 | Experimental | Drug: BI 498306 25 mg QD |
| dose 3 | Experimental | Drug: BI 498306 50 mg QD |
| dose 4 | Experimental | Drug: BI 409306 100 mg QD |
| placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients with established diagnoses of schizophrenia (per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)) with the following clinical features:
- b)-4 Anticholinergics, antiepileptics and lithium have been washed out for at least 6 months prior to randomisation if the treatments that patients were using before entering the clinical trial are discontinued.
- Male or female patients age 18 to 55 years
- Patients must exhibit reliability, physiologic capability, and an educational level sufficient to comply with all protocol procedures,in the investigator's opinion.
- Signed and dated written informed consent by date of Visit 1 in accordance with GCP and the local legislation. If the patient needs a legal representative, then this legal representative must give written informed consent as well.
Key exclusion criteria (23 listed)
- Patient treated with more than two antipsychotic medications (including more than two dosage forms)
- Patient's cognitive impairment severity compromises the validity of the cognitive outcome measures, in the clinical judgment of the investigator
- 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 Suicidal Severity Rating Scale (C-SSRS) 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 of the medical examination (including BP, PR and ECG) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 409306 100 mg QD | Drug | dose 4 |
| BI 498306 50 mg QD | Drug | dose 3 |
| Placebo | Drug | placebo |
| BI 498306 25 mg QD | Drug | dose 2 |
| BI 409306 10 mg QD | Drug | dose 1 |
Primary outcome
Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment
Time frame: Baseline and Week 12
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning problem solving, and social cognition. The composite score was calculated by summing over the standardised score of each domain for analysis and it varies from -20 to 99 with higher score indicating better outcome. The trial was set up as "learn and confirm" model including 2 stages. Stage 1 analysis was conducted to identify the meaningful cognition endpoint(s) (CANTAB domain(s)) and the selected endpoint(s) were to be pre-specified as the primary endpoint(s) for Stage 2 analysis. Since none of the CANTAB outcome measures was selected in the Stage 1 analysis at planned time based on the pre-specified criteria, the MCCB composite score was chosen as the primary endpoint in the Stage 2 analysis, as pre-defined.
Occurrence of Serious Adverse Events (SAEs) (Including the Abnormalities of Physical Examination, Vital Signs, Electrocardiogram (ECG) Test and Laboratory Tests)
Time frame: Up to 20 weeks
Occurrence of serious adverse events (SAEs) (including the abnormalities of physical examination, vital signs, electrocardiogram (ECG) test and laboratory tests).
Occurrence of Protocol-specified Adverse Events of Special Interest (AESI)
Time frame: Up to 20 weeks
Occurrence of Protocol-specified adverse events of special interest (AESI).
Dramatic Worsening of Disease State as Assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, Week 6 and Week 12
Dramatic worsening of disease state as assessed by Positive and Negative Syndrome Scale (PANSS). It contains 30-items including seven positive symptom items, seven negative symptom items and 16 general psychopathology symptom items. Each item was scored on the same seven point severity scale. Fourteen of the PANSS items required input from an informant. Total score ranges from 30 to 210 (minimum is better). The descriptive statistics of change from baseline (CFB) in PANSS score at week 6 (W6) and week 12 (W12) are presented.
Suicidality as Assessed by Columbia Suicidal Severity Rating Scale (C-SSRS)
Time frame: Up to 12 weeks
C-SSRS: Number (%) of subjects with an event of Suicidal Ideation (Wish to be dead, Non-specific active suicidal thoughts, Active suicidal ideation with any methods (not plan) without intent to act, Active suicidal ideation with some intent to act without specific plan, Active suicidal ideation with specific plan and intent) or Suicidal Behavior (Preparatory acts or behavior, Aborted attempt, Interrupted attempt, Non-fatal suicide attempt, Completed suicide) or Self-injurious behavior without suicidal intent is presented. C-SSRS used only to evaluate whether the patient developed suicidal ideation or behavior and no composite score will be used. Questions in the 1st section of suicidal ideation and suicidal behavior assessments in C-SSRS are "yes" and "no" type questions. If patient had suicidal ideation or behavior, 2nd section will be performed to evaluate the details with the scale from 0 to 5 or 0 to 2 and the larger number means the more severe condition.
5 secondary outcomes
Change From Baseline in Everyday Functional Capacity as Measured by Schizophrenia Cognition Rating Scale (SCoRS) Global Ratings After 12 Weeks of Treatment
Time frame: Baseline and Week 12
Change From Baseline in Clinical Global Impressions-Severity (CGI-S) Scale Score After 12 Weeks of Treatment
Time frame: Baseline and Week 12
Patient Global Impressions-Improvement (PGI-I) Scale Score Measured After 12 Weeks of Treatment
Time frame: Up to 12 weeks
Change From Baseline in PANSS Negative Symptom Factor Score After 12 Weeks of Treatment (for Subset of Patients Diagnosed With Negative Symptom)
Time frame: Baseline and Week 12
Change in Psychopathology Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, Week 6 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28956335Dorner-Ciossek C, Kroker KS, Rosenbrock H. Role of PDE9 in Cognition. Adv Neurobiol. 2017;17:231-254. doi: 10.1007/978-3-319-58811-7_9.
- Derived from this study: PubMed 28433500Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 409306 100 mg QD, BI 498306 50 mg QD and BI 498306 25 mg QD in people with Schizophrenia, run by Boehringer Ingelheim at 43 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Japan, Taiwan, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Composite Score of Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) After 12 Weeks of Treatment (time frame: Baseline and Week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02281773, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2017.