NCT03978832 is a Phase 4 clinical trial of PERSERIS in Schizophrenia, sponsored by Indivior Inc..

Who is sponsoring NCT03978832?

NCT03978832 is sponsored by Indivior Inc..

What drugs are being tested in NCT03978832?

Interventions in NCT03978832: PERSERIS, Risperidone.

What condition does NCT03978832 study?

NCT03978832 studies Schizophrenia.

Is NCT03978832 still recruiting?

NCT03978832 is currently completed. Last updated 7 July 2021.

Are results published for NCT03978832?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-07 · How we verify

NCT03978832

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability, Pharmacokinetics and Efficacy of 180 mg Subcutaneous Risperidone From 6 mg Oral Risperidone

Completed Phase 4 Results posted Last updated 7 July 2021

What this trial tests

Phase 4 trial testing PERSERIS in Schizophrenia in 69 participants. Completed in 12 May 2020.

Timeline

28 June 2019

Primary endpoint
12 May 2020

12 May 2020

Quick facts

Lead sponsor	Indivior Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	69
Start date	28 June 2019
Primary completion	12 May 2020
Estimated completion	12 May 2020
Sites	1 location across United States

Drugs / interventions tested

PERSERIS — full drug profile →
Risperidone (risperidone) — full drug profile →

Conditions studied

Schizophrenia — all drugs for Schizophrenia →

Sponsor

Indivior Inc. — full company profile →

Who can join

Adults 18 to 65, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Steady-state Average Plasma Concentration (Cavg,ss) of Risperidone and Total Active Moiety Primary · 0-12 hours post-dose on Day -1, and 0-672 hours after Dose 3

Cavg,ss for risperidone and total active moiety after oral and SC administration

Risperidone after oral dosing

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	5.150	± 43.3

Risperidone after Dose 3

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	10.200	± 65.3

Total active moiety after oral dosing

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	43.730	± 34.8

Total active moiety after Dose 3

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	44.049	± 24.4

Assessment of Local Injection Site Tolerability* Secondary · First injection at Day 1 until last injection administered at Day 85

Injection site tolerability was measured by injection site grading for redness, induration, swelling and tenderness/pain. These were graded on a scale from 0 to 4 for severity (none, mild, moderate, severe and potentially life-threatening)

Dose 1 injection site pain grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	22
Oral Risperidone Followed by PERSERIS	1

Dose 2 injection site pain grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	19
Oral Risperidone Followed by PERSERIS	1

Dose 3 injection site pain grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	16
Oral Risperidone Followed by PERSERIS	0

Dose 4 injection site pain grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	15
Oral Risperidone Followed by PERSERIS	1

Dose 1 injection site tenderness grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	21
Oral Risperidone Followed by PERSERIS	2

Dose 2 injection site tenderness grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	18
Oral Risperidone Followed by PERSERIS	2

Dose 3 injection site tenderness grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	15
Oral Risperidone Followed by PERSERIS	1

Dose 4 injection site tenderness grade

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	13
Oral Risperidone Followed by PERSERIS	3

The Number of Participants With TEAEs as Assessed by Local Injection Site* Secondary · First injection at Day 1 until Day 120

The injection site was evaluated for adverse events by observation and examination by appropriately trained personnel.

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

The Number of Participants With TEAEs as Assessed by Changes in Vital Signs Secondary · Time subjects sign the informed consent form throughout the study until EOS (Day 113)

Vital sign measurement was performed, including orthostatic blood pressure, and clinically significant changes were reported as adverse events (AE). Vital sign measurement also included measurement of pulse rate, oral temperature and respiratory rate. Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise expla

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

The Number of Participants With TEAEs as Assessed by Changes in ECG Secondary · Time participants sign the informed consent form throughout the study until EOS (Day 113)

ECGs were performed, and clinically significant changes in parameters were reported as adverse events (AE). ECGs were performed after 5 minutes of rest, and ECG parameters including QT interval, PR interval, QRS interval and heart rate was recorded. The ECG measurements were evaluated during the visit and determination of whether any abnormalities were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specifi

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0

The Number of Participants With TEAEs as Assessed by Changes in Body Weight Secondary · Time subjects sign the informed consent form throughout the study until EOS (Day 113)

Body weight, with shoes off, was measured and clinically significant changes in weight was reported as adverse events (AE). Determination of whether the changes were AEs was made by the investigator or a medically qualified designee. If determined to be an AE, the measurement was repeated at appropriate intervals until the value returned to an acceptable range and the subject was clinically stable, a specific diagnosis was established, or the condition otherwise explained.

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

The Number of Participants With TEAEs as Assessed by Changes in Laboratory Testing Secondary · Time subjects sign the informed consent form throughout the study until end of study (EOS) visit (Day 113)

Laboratory testing was performed by the local clinical laboratory accredited by the College of American Pathologists, and clinically significant changes from baseline were reported as AEs. Subjects were expected to fast for a minimum of 8 hours prior to blood draws for all laboratory assessments except at the screening visit. Prior to entering the study, any abnormal laboratory test results were to be considered not clinically significant. Any abnormal hematology, serum chemistry or urinalysis test result after study drug intake that was determined by the investigator or a medically qualified

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	3

The Number of Participants With TEAEs as Assessed by Extrapyramidal Symptoms (EPS) of Anti-psychotic Drug Treatment Secondary · Time subjects sign the informed consent form throughout the study until EOS (Day 113)

Safety of treatment was measured by administration of symptom questionnaires including AIMS, Barnes Akathisia Rating Scale (BARS) and Simpson-Angus Scale (SAS), as well as by assessment by the investigator or suitably qualified medical designee. The AIMS is a tool that aids in early detection and ongoing monitoring of tardive dyskinesia, a movement disorder. The BARS is a 4-item scale that detects the presence and severity of any drug-induced restlessness. The SAS is a 10-item scale used to detect the presence of drug-induced Parkinsonism (movement disorder seen in Parkinson's disease) and ext

Akathisia

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

Dyskinesia

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	2

Parkinsonian gait

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

Tremor

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	1

Positive and Negative Syndrome Scale (PANSS) Secondary · Baseline, defined as last assessment prior to first injection, through Day 113 (EOS)

Clinical outcome (efficacy endpoint) as measured by change from baseline in PANSS scores was measured. PANSS is a medical scale designed to measure schizophrenia symptom severity utilizing a 30 item, 7-point rating scheme. The PANSS Is scored by a summation of ratings across items, with a total potential range of 7-210; higher results indicate greater severity of illness. Only total score changes from baseline are reported here.

Total score change from baseline: Dose 1 Day 2

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.2	± 3.52

Total score change from baseline: Dose 1 Day 8

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.9	± 3.91

Total score change from baseline: Dose 1 Day 15

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.7	± 4.81

Total score change from baseline: Dose 1 Day 22

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.4	± 4.16

Total score change from baseline: Dose 2 Day 29

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.9	± 5.05

Total score change from baseline: Dose 2 Day 50

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.5	± 7.21

Total score change from baseline: Dose 3 Day 57

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-2.9	± 4.92

Total score change from baseline: Dose 4 Day 85

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.9	± 6.00

Clinical Global Impression-Severity of Illness Scale (CGI-S) Secondary · Baseline through EOS (Day 113)

Clinical outcome (efficacy endpoint) as measured by change from baseline in CGI-S scores was measured. The CGI-S is a measurement of the total severity of illness where one question is assessed. Responses range from 0 (not assessed) to 7 (most extremely ill).

Change from baseline: Dose 1/Day 2

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	-0.1	± 0.29

Change from baseline: Dose 1/Day 8

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.21

Change from baseline: Dose 1/Day 15

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.38

Change from baseline: Dose 1/Day 22

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.44

Change from baseline: Dose 2/Day 29

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.44

Change from baseline: Dose 2/Day 50

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.47

Change from baseline: Dose 3/Day 57

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.1	± 0.44

Change from baseline: Dose 4/Day 85

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.1	± 0.50

Columbia-Suicide Severity Rating Scale (C-SSRS)-Change Secondary · Screening through EOS (Day 113)

Significant changes from baseline in C-SSRS scores were reported as adverse events. The C-SSRS is based on a categorization of thoughts and behavior that are identified as related to suicidal behavior. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviors throughout lifetime at screening and for the time interval since last administration during a study. Responses are indicated as yes (thought or behavior did occur) or no (thought or behavior did not occur). If a yes response is received, then follow up questions are asked. The outcome of the C-SSR

Change in Maximum Suicidal Ideation at Dose 1/Day 8

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Change in Maximum Suicidal Ideation at EOS

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Change in Suicidal Ideation Intensity Score at Dose 1/Day 8

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Change in Suicidal Ideation Intensity Score at EOS

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Change in Maximum Suicidal Behavior at Dose 1/Day 8

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Change in Maximum Suicidal Behavior at EOS

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	0.0	± 0.00

Safety as Measured by Columbia-Suicide Severity Rating Scale (C-SSRS) Scores Secondary · Screening through EOS (Day 113)

Safety of treatment was measured by characterization of thoughts and behavior related to suicidal behavior. This was assessed by administration of the C-SSRS at designated visits. The scale captures the occurrence, severity and frequency of suicide related thoughts and behaviours throughout lifetime at screening and for the time interval since last administration during a study. Questions solicit the type of information needed to determine if a suicide-related thought or behavior occurred.

Any Suicidal Ideation - Lifetime

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	15
Oral Risperidone Followed by PERSERIS	8

Any Suicidal Ideation - Past 6 months

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	23
Oral Risperidone Followed by PERSERIS	0

Any Suicidal Ideation - EOS

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	14
Oral Risperidone Followed by PERSERIS	0

Any Suicidal Behavior - Lifetime

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	17
Oral Risperidone Followed by PERSERIS	6

Any Suicidal Behavior - Past 6 months

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	20
Oral Risperidone Followed by PERSERIS	0

Any Suicidal Behavior - EOS

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	14
Oral Risperidone Followed by PERSERIS	0

Any Suicidal Ideation or Behavior - Lifetime

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	15
Oral Risperidone Followed by PERSERIS	8

Any Suicidal Ideation or Behavior - Past 6 months

Group	Value	95% CI
Oral Risperidone Followed by PERSERIS	20
Oral Risperidone Followed by PERSERIS	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from the time of informed consent through the end of study for each subject, Day 120, a total of up to 146 days including the screening and dosing stabilization periods.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Oral Risperidone Followed by PERSERIS

Serious: 1/23 (4%)

Deaths: 0/23

Serious adverse events (1 terms)

Reaction	System	Oral Risperidone Followed …
increase in liver enzymes	Hepatobiliary disorders	—

Other adverse events (6 terms — click to expand)

Reaction	System	Oral Risperidone Followed …
upper respiratory tract infection	Infections and infestations	—
blood prolactin increased	Investigations	—
decreased appetite	Metabolism and nutrition disorders	—
dyskinesia	Nervous system disorders	—
fall	Injury, poisoning and procedural complications	—
headache	Nervous system disorders	—

Most-reported serious reactions: increase in liver enzymes.

Data from ClinicalTrials.gov NCT03978832 adverse events section.

Sponsor's own description

This study evaluates PERSERIS at a higher dose than what has been administered in previous clinical trials. Subjects with stable schizophrenia on a dose of 5-6 mg oral risperidone will be switched to PERSERIS at the higher dose, which is believed to be similar to the oral dose

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Role of adrenergic receptor signalling in neuroimmune communication.
Chhatar S, Lal G. · · 2021 · cited 76× · PMID 35492402 · DOI 10.1016/j.crimmu.2021.11.001
An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients.
Walling DP, Shinde SN, Pogoda JM, Kharidia J, et al · · 2024 · cited 1× · PMID 38388986 · DOI 10.1007/s40261-024-01347-1

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03978832 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indivior Inc.
Last refreshed: 7 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03978832.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing