ClinicalTrials.gg
TerminatedNCT03420222Updated May 24, 2022Results posted

Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder

A Phase 2 interventional study of AVP-786 and Placebo in Intermittent Explosive Disorder, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Terminated at 9 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.

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Phase
Phase 2
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States — 8 open to participants now, 8 under way, none of them phase 3. Disruptive, Impulse Control, and Conduct Disorders · United States.

Enrollment
27th of 28
10 · median 48
Started
2018
the only one that year
Phase 2
14 of 31
4 open now
Registered
21st of 31
by date

Among the 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States, this one is the 27th largest by enrollment of the 28 interventional ones that give a count, is the only one that started in 2018, is one of 14 in phase 2, and was the 21st registered.

Disruptive, Impulse Control, and Conduct Disorders

56 studies on the registry are indexed under Disruptive, Impulse Control, and Conduct Disorders; 17 are open to participants now.

Browse Disruptive, Impulse Control, and Conduct Disorders studies →

Open to participants now

8 of the 31 studies in Disruptive, Impulse Control, and Conduct Disorders with a site in United States are open now. Recruiting first, the newest first:

3 more — sign in →

All 8 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 15 Disruptive, Impulse Control, and Conduct Disorders studies recruiting now, 4 (27%) set no upper age limit and 10 (67%) stop at 75 or younger; none take children under 18; 5 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

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02

Study summary

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786 for the treatment of Intermittent Explosive Disorder (IED).

Read the 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.

03

Conditions studied

  • Intermittent Explosive Disorder

Keywords

  • Intermittent Explosive Disorder
  • AVP-786
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of current Intermittent Explosive Disorder (IED) according to the , 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

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 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)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    AVP-786

    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.

    Drug: AVP-786

  • Placebo comparator
    Placebo

    Participants were to receive placebo BID for 12 weeks.

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline; Week 12

Secondary outcomes

  1. 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.

    Time frame: Baseline; Week 12

  2. 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.

    Time frame: Baseline; Week 12

  3. 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.

    Time frame: Baseline; Week 12

  4. 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.

    Time frame: Baseline; Week 12

  5. 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.

    Time frame: Baseline; Week 12

  6. 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.

    Time frame: Baseline; Week 12

  7. 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).

    Time frame: Baseline; Week 12

  8. 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).

    Time frame: Baseline; Week 12

  9. 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.

    Time frame: Baseline; Week 12

  10. 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).

    Time frame: Baseline; Week 12

  11. 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).

    Time frame: Baseline; Week 12

  12. 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).

    Time frame: Baseline; Week 12

  13. 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).

    Time frame: Baseline; Week 12

  14. 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.

    Time frame: Baseline; Week 12

  15. 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.

    Time frame: Baseline; Week 12

  16. 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).

    Time frame: Baseline; Week 12

07

Results

Posted May 24, 2022
Limitations and caveats
Due to limited enrollment (N=10), this clinical trial was terminated by the Sponsor.

Participant flow

Participant flow — Overall Study
MilestoneAVP-786Placebo
Started82
Completed31
Not completed51
Withdrew: Withdrawal by subject50
Withdrew: Physician decision01

Outcome measures

PrimaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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.

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

SecondaryChange 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).

Time frame:
Baseline; Week 12

No measurements were reported for this outcome.

Adverse events

Collected over Up to Day 85. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
AVP-7860/8 (0%)0/8 (0%)4/8 (50%)
Placebo0/2 (0%)0/2 (0%)2/2 (100%)
Most frequent other events
Showing 10 of 12
Most frequent other events
EventAVP-786Placebo
Aspartate aminotransferase increasedInvestigations0/81/2
Blood creatine phosphokinase increasedInvestigations0/81/2
Electrocardiogram ST segment elevationInvestigations0/81/2
Haematocrit decreasedInvestigations0/81/2
Haemoglobin decreasedInvestigations0/81/2
NauseaGastrointestinal disorders0/81/2
VomitingGastrointestinal disorders0/81/2
DizzinessNervous system disorders1/80/2
HeadacheNervous system disorders1/80/2
NervousnessPsychiatric disorders1/80/2

Baseline characteristics

Age, Continuous
Age, Continuous(years)AVP-786PlaceboTotal
MeanNA ± NANA ± NANA ± NA
Sex: Female, Male
Sex: Female, Male(Participants)AVP-786PlaceboTotal
FemaleNANANA
MaleNANANA
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AVP-786PlaceboTotal
American Indian or Alaska NativeNANANA
AsianNANANA
Native Hawaiian or Other Pacific IslanderNANANA
Black or African AmericanNANANA
WhiteNANANA
More than one raceNANANA
Unknown or Not ReportedNANANA
08

Study locations

9 sites
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
  • Atlanta Center for Medical Research
    Atlanta, Georgia 30331, United States
  • University of Chicago Medical Center Clinical Trial Site 2
    Chicago, Illinois 60637, United States
  • BTC of New Bedford
    New Bedford, Massachusetts 01740, United States
  • Psychiatric Care and Research Center
    O'Fallon, Missouri 63368, United States
  • Atlea Research Institute
    Las Vegas, Nevada 89102, United States
  • Montefiore Medical Center
    Bronx, New York 10467, United States
  • Manhattan Behavioral Medicine
    New York, New York 10036, United States
  • Research Institute Lindner Center of Hope/University of Cincinnati
    Mason, Ohio 45040, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

Access criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Data sharing details ↗ · clinical-trials.otsuka.com

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2018 to primary completion in Dec 2018, 11 months.

Results were first posted in May 2022, 3 years 4 months after primary completion. A results delay was requested in Dec 2019.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2018
First posted
Feb 5, 2018
StartActual
Jan 18, 2018
Primary completionActual
Dec 28, 2018
CompletionActual
Dec 28, 2018
Results delay requested
Dec 20, 2019
Results first posted
May 24, 2022
Last update
May 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03420222
Responsible party
Sponsor
First posted
Feb 5, 2018
Start date
Jan 18, 2018
Primary completion
Dec 28, 2018
Completion
Dec 28, 2018
Results posted
May 24, 2022
Last update
May 24, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Deudextromethorphan · Quinidine

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