Back to resultsStudy to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Primary Purpose
Intermittent Explosive Disorder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AVP-786
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Explosive Disorder focused on measuring Intermittent Explosive Disorder, AVP-786
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
- At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
- Score ≥ 12 on the Life History of Aggression scale at screening
- Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
- Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
Exclusion Criteria:
- Diagnosis of major depressive disorder within 6 months of screening
- Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
- Met only the DSM-5 A2 criterion for IED
- Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
- Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
Sites / Locations
- Sarkis Clinical Trials
- Atlanta Center for Medical Research
- University of Chicago Medical Center Clinical Trial Site 2
- BTC of New Bedford
- Psychiatric Care and Research Center
- Atlea Research Institute
- Montefiore Medical Center
- Manhattan Behavioral Medicine
- Research Institute Lindner Center of Hope/University of Cincinnati
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AVP-786
Placebo
Arm Description
Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
Participants were to receive placebo BID for 12 weeks.
Outcomes
Primary Outcome Measures
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
Secondary Outcome Measures
Change From Baseline in the OAS-M Total Irritability Score at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M irritability domain includes 2 global assessment items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all to 5 = extreme). The 2 scores are added to create the OAS-M Total Irritability score (range = 0 to 10). Higher scores indicate increased irritability.
Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault). Higher scores indicate increased aggression.
Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M irritability domain includes 2 items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all; 5 = extreme). Higher scores indicate increased irritability.
Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
The IED episodes were to be documented by the participants each evening before bedtime.
Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
The IED episodes were to be documented by the participants each evening before bedtime and reviewed by the Investigator post dose.
Change From Baseline in the Number of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes.
Change From Baseline in the Severity of IED Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of the worst episode (0 = not severe at all to 10 = worst severity imaginable).
Change From Baseline in the Severity of Distress From Episodes at Week 12
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of distress experienced by the episode(s) (0 = no distress to 10 = worst distress imaginable).
Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M includes information regarding the number of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) A1 aggressive episodes, and the number of DSM-5 A2 aggressive episodes experienced by the participants during the past week. The number of discrete IED episodes is calculated after an interview with the participant. Episodes identified as discrete are separated by at least 30 minutes; episodes separated by less than 30 minutes are considered a single episode.
Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
The mCGI-S is a modified version of the CGI-S scale that provides a global evaluation of the participant's IED symptoms (e.g., aggression, anger, and irritability). The mCGI-S scale measures the severity of the participant's symptoms from the clinician's perspective in the context of other participants with IED. The mCGI-S responses are scored on a 7- point scale (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants).
Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
The mCGI-C is a modified version of the CGI-C scale. The clinician rates the overall global change in the participant's IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double- blind visits. The mCGI-C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
The mPGI-S is a single-question scale. Participants rate the overall global severity of their IED symptoms (e.g., aggression, anger, and irritability) using a 7-point scale (1 = normal, no symptoms; 2 = borderline symptoms; 3 = mild symptoms; 4 = moderately bad symptoms; 5 = markedly bad symptoms; 6 = severely bad symptoms; 7 = extremely bad symptoms).
Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
The mPGI-C is a single-question scale. Participants rate the overall global change in their IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double-blind visits. The mPGI- C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
The SDS is a 3-item, participant-rated questionnaire used to evaluate impairments in the domains of work/school, social life or leisure activities, and family life or home responsibility. Participants rate the degree of impairment in work/school, social life or leisure activities, and family life or home responsibility as a result of IED symptoms using a visual analogue scale (0 = no impairment; 1, 2, 3 = mildly; 4, 5, 6 = moderately; 7, 8, 9 = markedly; 10 = extremely). Only those score categories with at least one participant with event are reported.
Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
The SF-12 is a 12-item, participant self-rated questionnaire used to measure the general health status and quality of life. The SF-12 includes questions to measure the effects of health on physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100. Higher scores indicate better health status.
Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
The STAXI-2 is a 57-item, participant self-rated scale used to measure the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 includes a measure of state anger, trait anger, anger expression-out, anger expression-in, anger control-out and anger control, and the anger expression index (an overall measure of the expression and control of anger). The state anger items are scored using a 4-point scale (1 = not at all to 4 = very much so) to assess the intensity of anger feelings at a particular moment. The other scales are scored using a 4- point scale to assess how frequently angry feelings are experienced, expressed, suppressed, or controlled (1 = almost never to 4 = almost always).
Full Information
NCT ID
NCT03420222
First Posted
January 19, 2018
Last Updated
April 29, 2022
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03420222
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Official Title
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Intermittent Explosive Disorder (IED)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
December 28, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).
Detailed Description
Eligible participants for this study must have a diagnosis of current IED.
This is a multicenter, randomized, double-blind, placebo-controlled study, consisting of up to 12 weeks of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Explosive Disorder
Keywords
Intermittent Explosive Disorder, AVP-786
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AVP-786
Arm Type
Experimental
Arm Description
Participants were to receive AVP-786-28 (deudextromethorphan hydrobromide [d6-DM] 28 milligrams [mg]/quinidine sulfate [Q] 4.9 mg) once daily (OD) for the first 7 days, followed by AVP-786-28 twice daily (BID) for the next 7 days. Beginning on Day 15, participants were to receive AVP-786-42.63 (d6-DM 42.63 mg/Q 4.9 mg) BID for 10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants were to receive placebo BID for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
AVP-786
Intervention Description
oral capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral capsules
Primary Outcome Measure Information:
Title
Change From Baseline in the Overt Aggression Scale - Modified for Outpatient Use (OAS-M) Total Aggression Score at Week 12
Description
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x 3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault within that category). The weighted individual item scores are added to obtain the OAS-M Total Aggression score. Higher scores indicate increased aggression.
Time Frame
Baseline; Week 12
Secondary Outcome Measure Information:
Title
Change From Baseline in the OAS-M Total Irritability Score at Week 12
Description
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M irritability domain includes 2 global assessment items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all to 5 = extreme). The 2 scores are added to create the OAS-M Total Irritability score (range = 0 to 10). Higher scores indicate increased irritability.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the OAS-M Individual Items for Aggression at Week 12
Description
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M aggression domain includes 4 items: verbal assault, assault against objects, assault against others, and assault against self. The rater determines the frequency of each response (item) during the past week, and the frequency of each item is multiplied by the severity level (0 to 5), producing a raw score. This raw score is multiplied by severity weight for that item (verbal assault x 1, assault against objects x 2, assault against others x3, and assault against self x 3). Each response is scored using a 6-point scale (0 = no events to 5 = most severe form of assault). Higher scores indicate increased aggression.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the OAS-M Individual Items for Irritability at Week 12
Description
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression and irritability. The OAS-M irritability domain includes 2 items: global subjective irritability and global overt irritability. Each response is scored using a 6-point scale (0 = not at all; 5 = extreme). Higher scores indicate increased irritability.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Number of Intermittent Explosive Disorder (IED) Days Documented by Participants at Week 12
Description
The IED episodes were to be documented by the participants each evening before bedtime.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Number of IED Days as Assessed by the Investigator at Week 12
Description
The IED episodes were to be documented by the participants each evening before bedtime and reviewed by the Investigator post dose.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Number of IED Episodes at Week 12
Description
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Severity of IED Episodes at Week 12
Description
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of the worst episode (0 = not severe at all to 10 = worst severity imaginable).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Severity of Distress From Episodes at Week 12
Description
The IED episodes were to be documented by the participants each evening before bedtime. If the participant indicated that he/she experienced an IED episode, he/she was to document the number of episodes and to rate the severity of distress experienced by the episode(s) (0 = no distress to 10 = worst distress imaginable).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the OAS-M: Number of Discrete IED Episodes at Week 12
Description
The OAS-M is a clinical-administered instrument designed to assess various manifestations of aggressive behavior through 2 domains: aggression, and irritability. The OAS-M includes information regarding the number of Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) A1 aggressive episodes, and the number of DSM-5 A2 aggressive episodes experienced by the participants during the past week. The number of discrete IED episodes is calculated after an interview with the participant. Episodes identified as discrete are separated by at least 30 minutes; episodes separated by less than 30 minutes are considered a single episode.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Modified Clinical Global Impression of Severity (mCGI-S) Score for IED at Week 12
Description
The mCGI-S is a modified version of the CGI-S scale that provides a global evaluation of the participant's IED symptoms (e.g., aggression, anger, and irritability). The mCGI-S scale measures the severity of the participant's symptoms from the clinician's perspective in the context of other participants with IED. The mCGI-S responses are scored on a 7- point scale (1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Modified Clinical Global Impression of Change (mCGI-C) Score for IED at Week 12
Description
The mCGI-C is a modified version of the CGI-C scale. The clinician rates the overall global change in the participant's IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double- blind visits. The mCGI-C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Modified Patient Global Impression of Severity (mPGI-S) Score for IED at Week 12
Description
The mPGI-S is a single-question scale. Participants rate the overall global severity of their IED symptoms (e.g., aggression, anger, and irritability) using a 7-point scale (1 = normal, no symptoms; 2 = borderline symptoms; 3 = mild symptoms; 4 = moderately bad symptoms; 5 = markedly bad symptoms; 6 = severely bad symptoms; 7 = extremely bad symptoms).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Modified Patient Global Impression of Change (mPGI-C) Score for IED at Week 12
Description
The mPGI-C is a single-question scale. Participants rate the overall global change in their IED symptoms (e.g., aggression, anger, and irritability) from Baseline at the scheduled double-blind visits. The mPGI- C responses are scored using a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse).
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Sheehan Disability Scale (SDS) Score at Week 12
Description
The SDS is a 3-item, participant-rated questionnaire used to evaluate impairments in the domains of work/school, social life or leisure activities, and family life or home responsibility. Participants rate the degree of impairment in work/school, social life or leisure activities, and family life or home responsibility as a result of IED symptoms using a visual analogue scale (0 = no impairment; 1, 2, 3 = mildly; 4, 5, 6 = moderately; 7, 8, 9 = markedly; 10 = extremely). Only those score categories with at least one participant with event are reported.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the Short-Form 12-Item Health Survey (SF-12) Score at Week 12
Description
The SF-12 is a 12-item, participant self-rated questionnaire used to measure the general health status and quality of life. The SF-12 includes questions to measure the effects of health on physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores range from 0 to 100. Higher scores indicate better health status.
Time Frame
Baseline; Week 12
Title
Change From Baseline in the State-Trait Anger Expression Inventory-2 (STAXI-2) Score at Week 12
Description
The STAXI-2 is a 57-item, participant self-rated scale used to measure the intensity of anger as an emotional state (state anger) and the disposition to experience angry feelings as a personality trait (trait anger). The STAXI-2 includes a measure of state anger, trait anger, anger expression-out, anger expression-in, anger control-out and anger control, and the anger expression index (an overall measure of the expression and control of anger). The state anger items are scored using a 4-point scale (1 = not at all to 4 = very much so) to assess the intensity of anger feelings at a particular moment. The other scales are scored using a 4- point scale to assess how frequently angry feelings are experienced, expressed, suppressed, or controlled (1 = almost never to 4 = almost always).
Time Frame
Baseline; Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited by the Structured Clinical Interview for DSM-5, Clinical Trials Version
At least 3 IED days (at least 1 IED episode each day, as recorded by the participant) per week for the 2 consecutive weeks directly preceding baseline with 70% compliance during that time frame, as assessed by the investigator
Score ≥ 12 on the Life History of Aggression scale at screening
Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and baseline
Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening and baseline
Exclusion Criteria:
Diagnosis of major depressive disorder within 6 months of screening
Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9 score ≥ 10 at screening
Met only the DSM-5 A2 criterion for IED
Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder, antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5 criteria)
Recurrent IED episodes that are better explained by another mental disorder or attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or to the physiological effect of a substance (e.g., a drug of abuse, a medication) (DSM-5 criteria)
Facility Information:
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Facility Name
University of Chicago Medical Center Clinical Trial Site 2
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
BTC of New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
01740
Country
United States
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Facility Name
Atlea Research Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Manhattan Behavioral Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Research Institute Lindner Center of Hope/University of Cincinnati
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
IPD Sharing Time Frame
Data will be available after marketing approval in global markets or beginning 1-3 years following article publication. There is no end date to the availability of the data.
IPD Sharing Access Criteria
Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/
IPD Sharing URL
https://clinical-trials.otsuka.com
Learn more about this trial
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
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