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SchizophreniaPhase 2/3NCT03896945

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Negative Symptoms of Schizophrenia

A Phase 2/3 study testing AVP-786 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 72 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
AVP-786
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
136 participants
Where
72 sitesin 4 countries
Study dates
15 Feb 2019to 23 May 2023
Phase
Phase 2/3
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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-V) diagnostic criteria for schizophrenia confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I) Version 7.0.2
  • Participants must have well-controlled positive symptoms and prominent negative symptoms as defined by Positive and Negative Syndrome Scale (PANSS) criteria.
  • Participants currently receiving a second-generation atypical antipsychotic drug (SGA) are eligible if they are stable and adherent to their dosing schedule.
  • Participants must have a reliable informant (e.g., case manager, social worker, family member). The informant should be able to spend an adequate amount of time with the participant to be able to address behaviors, activities, and symptoms.

Who cannot join

  • Participants with current major depressive disorder (MDD)
  • Participants with pseudo-parkinsonism secondary to their ongoing antipsychotic medication
  • Participants currently using anticholinergic medications
  • Participants recently hospitalized as in-patients

Trial locations and contacts

72 sites in 4 countries.

72 sites in 4 countries

United States61 sites

  • Clinical Research Site #840-041

    Anaheim, California, 92805

  • Clinical Research Site #840-088

    Atlanta, Georgia, 30303

  • Clinical Research Site #840-091

    Atlanta, Georgia, 30318

  • Clinical Research Site #840-008

    Atlanta, Georgia, 30328

  • Clinical Research Site #840-013

    Bellflower, California, 90706

  • Clinical Research Site #840-028

    Berlin, New Jersey, 08009

  • Clinical Research Site #840-074

    Charlotte, North Carolina, 28211

  • Clinical Research Site

    Chicago, Illinois, 60640

  • Clinical Research Site #840-079

    Costa Mesa, California, 92626

  • Clinical Research Site #840-027

    Culver City, California, 90230

  • Clinical Research Site #840-063

    Decatur, Georgia, 30030

  • Clinical Research Site

    DeSoto, Texas, 75115

  • Clinical Research Site# 840-094

    Doral, Florida, 33178

  • Clinical Research Site

    Edmond, Oklahoma, 73013

  • Clinical Research Site #840-051

    Everett, Washington, 98201

  • Clinical Research Site #840-057

    Flowood, Mississippi, 39232

  • Clinical Research Site #840-058

    Fort Worth, Texas, 76104

  • Clinical Research Site #840-006

    Garden Grove, California, 92845

  • Clinical Research Site #840-026

    Glendale, California, 91206

  • Clinical Research Site #840-046

    Hollywood, Florida, 33021

  • Clinical Research Site Site #840-093

    Homestead, Florida, 33030

  • Clinical Research Site #840-009

    Jamaica, New York, 11432

  • Clinical Research Site# 840-067

    La Habra, California, 90631

  • Clinical Research Site# 840-083

    Lafayette, California, 94549

  • Clinical Research Site

    Lake Charles, Louisiana, 70629

  • Clinical Research Site #840-062

    Lakeland, Florida, 33803

  • Clinical Research Site #840-024

    Largo, Florida, 33770

  • Clinical Research Site 840-002

    Lemon Grove, California, 91945

  • Clinical Research Site

    Little Rock, Arkansas, 72209

  • Clinical Research Site #840-061

    Media, Pennsylvania, 19063

  • Clinical Research Site

    Memphis, Tennessee, 38119

  • Clinical Research Site #840-032

    Miami, Florida, 33122

  • Clinical Research Site #840-080

    Miami, Florida, 33173

  • Clinical Research Site #840-084

    Miami Lakes, Florida, 33014

  • Clinical Research Site #840-052

    Middleburg Heights, Ohio, 44130

  • Clinical Research Site #840-099

    Myrtle Beach, South Carolina, 28117

  • Clinical Research Site #840-070

    New York, New York, 10027

  • Clinical Research Site

    Norristown, Pennsylvania, 19401

  • Clinical Research Site

    Oakland, California, 94607

  • Clinical Research Site #840-035

    Oceanside, California, 92056

  • Clinical Research Site

    Okeechobee, Florida, 34972

  • Clinical Research Site #840-065

    Oklahoma City, Oklahoma, 73112

  • Clinical Research Site #840-040

    Olivette, Missouri, 63132

  • Clinical Research Site# 840-010

    Panorama City, California, 91402

  • Clinical Research Site #840-018

    Richardson, Texas, 75080

  • Clinical Research Site #840-012

    Riverside, California, 92506

  • Clinical Research Site

    Rochester, New York, 14618

  • Clinical Research Site #840-029

    Saint Charles, Missouri, 63304

  • Clinical Research Site #840-034

    Saint Charles, Missouri, 63304

  • Clinical Research Site

    San Antonio, Texas, 78229

  • Clinical Research Site# 840-081

    San Bernardino, California, 92408

  • Clinical Research Site #840-005

    San Diego, California, 92102

  • Clinical Research Site #840-096

    Santee, California, 92071

  • Clinical Research Site #840-098

    Shreveport, Louisiana, 71101

  • Clinical Research Site #840-090

    Springfield, Illinois, 62702

  • Clinical Research Site #840-069

    Springville, Utah, 84663

  • Clinical Research Site

    St Louis, Missouri, 63109

  • Clinical Research Site #840-025

    St Louis, Missouri, 63118

  • Clinical Research Site #840-015

    Torrance, California, 90502

  • Clinical Research Site # 840-102

    Weston, Florida, 33331

  • Clinical Research Site #840-072

    Worcester, Massachusetts, 01605

Other trials in United States

Bulgaria6 sites

  • Clinical Research Site #009

    Kazanlak, 6100

  • Clinical Research Site #100-008

    Novi Iskar, 1282

  • Clinical Research Site #100-007

    Plovdiv, 4004

  • Clinical Research Site #100-004 2

    Sofia, 1680

  • Clinical Research Site #100-006

    Veliko Tarnovo, 5000

  • Clinical Research Site #100-001

    Vratsa, 3000

Other trials in Bulgaria

Poland3 sites

  • Clinical Research Site #616-002

    Bełchatów, 97-400

  • Clinical Research Site #616-003

    Pruszcz Gdański, 80-300

  • Clinical Research Site

    Tuszyn, Woj.Iodzkie, 95-080

Other trials in Poland

Puerto Rico2 sites

  • Clinical Research Site #630-001

    San Juan, 918

  • Clinical Research Site # 630-002

    San Juan, 926

Other trials in Puerto Rico

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deudextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Negative Symptoms of Schizophrenia

This study was conducted to evaluate the efficacy, safety, and tolerability of AVP-786, as compared with placebo, for the treatment of negative symptoms of schizophrenia.

Conditions
Schizophrenia
Being tested
Placebo, AVP-786
Keywords
Negative Symptoms, Schizophrenia, AVP-786
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    oral capsules

  • AVP-786Drug

    oral capsules

Study groups in NCT03896945
Study groupRoleWhat they receive
Placebo (Run-in Period)Placebo comparatorParticipants received AVP-786 matching placebo capsules, orally, twice a day (BID) over a 3-week run-in period.
Receives: Drug: Placebo
AVP-786ExperimentalParticipants received AVP-786-28/4.9 (deudextromethorphan hydrobromide (d6-DM) 28 milligrams (mg)/quinidine sulfate (Q) 4.9 mg) capsule, along with AVP-786 matching placebo capsule, orally, once daily (QD) for 3 days followed by AVP-786-28/4.9 capsule, orally, BID for the next 4 days of titration period. Following the 1-week titration period, participants received AVP-786-42.63/4.9 (d6-DM 42.63 mg/Q 4.9 mg), orally, BID for the remaining 11 weeks of the DBT period.
Receives: Drug: AVP-786
PlaceboPlacebo comparatorParticipants received AVP-786 matching placebo capsules, orally, BID over a 12-week DBT period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline (Week 3) to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score

    The PANSS is a validated clinical scale used as a reliable and valid measure of the negative and positive symptom of schizophrenia. PANSS consists of three subscales: a total of 30 disparate items. Each item's severity was rated on a 7-point scale, with a score of 1 (absence of symptoms) and a score of 7 (extremely severe symptoms). The PANSS marder negative factors score is comprised of the following 7 items of the 30-item PANSS: blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, lack of spontaneity and flow of conversation, motor retardation and active social avoidance. The PANSS Negative Subscale ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). PANSS total score range is 30 to 210, with higher scores indicating more severe symptoms. Negative change from baseline indicates improvement. Baseline is defined as the end of the placebo run-in period (Week 3), and to be the last assessment prior to the first dose of study drug.

    Measured: Baseline (Week 3); Week 15

Secondary outcomes (3)

  1. Change From Baseline (Week 3) to Week 15 in the Negative Symptom Assessment-16 (NSA-16) Global Negative Symptom Score

    NSA-16=clinician-rated scale assessing presence, severity, \& range of negative symptoms associated with schizophrenia. It consists of 16 items \& uses 5-factor model to describe negative symptoms: communication (1-4, range=4-24), emotional/affective (5-7, range=3-18), social involvement (8-10, range=3-18), motivational (11-14, range=4-24), \& retardation (15-16, range=3-18) \&Global Negative Symptom Rating. NSA-16 items are rated on 6-point scale, 1=behavior is normal to 6=behavior severely reduced. Each item admits score of 9 if item is not ratable. Global Negative Symptom Rating range is 1=no evidence of symptoms to 7=extremely severe symptoms. 16 items yield a total of 16-96, with higher score indicating greater clinical severity of symptoms. Global rating range is 1-7, with higher score indicating extremely severe symptom. If more than 3 items were not ratable, total score was not evaluable \& was regarded as missing. Negative change from baseline indicates improvement.

    Measured: Baseline (Week 3); Week 15

  2. Change From Baseline (Week 3) to Week 15 in the Patient Global Impression of Severity (PGI-S) Score

    The severity of participants illness with respect to their schizophrenia was rated using a 7-point PGI-S. PGI-S scores range from 1 to 7, where 1= normal, not at all ill, 2= borderline ill, 3=mildly ill, 4=moderately ill, 5= markedly ill, 6=severely ill, 7=extremely ill. Missing PGI-S rating were not imputed. Negative change from baseline indicates improvement. Baseline is defined as the end of the placebo run-in period (Week 3), and to be the last assessment prior to the first dose of study drug.

    Measured: Baseline (Week 3); Week 15

  3. Patient Global Impression of Change (PGI-C) Score

    The PGI-C is a 7-point (1-7) participant-rated scale used to assess treatment response with respect to schizophrenia as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, or 7 = very much worse. Missing PGI-C rating were not imputed. .

    Measured: At Weeks 6, 9, 12 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2019
  2. Study start15 Feb 2019
  3. Primary completion23 May 2023
  4. Study completion23 May 2023

Why it stopped: Based on the Interim Analysis outcome and recommendation by the DMC, Otsuka approved termination of the study based on futility.

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03896945
Sponsor's protocol ID
18-AVP-786-207
Other IDs
2021-001352-33
Status last verified
Sep 2026
First submitted
19 Mar 2019
Last updated
29 Sep 2026
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing AVP-786 in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 72 sites in 4 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States, Bulgaria, Poland, Puerto Rico. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 29 Sep 2026). 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 (Week 3) to Week 15 in the Positive and Negative Syndrome Scale (PANSS) Marder Negative Factors Score (time frame: Baseline (Week 3); Week 15). 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 NCT03896945.

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 29 Sep 2026.

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