Acute SchizophreniaPhase 2REFRESHNCT01490086

RP5063 in Subjects With Schizophrenia or Schizoaffective Disorder

A Phase 2 study testing RP5063 and aripiprazole in people with Acute Schizophrenia and Schizoaffective Disorder, run by Reviva Pharmaceuticals at 15 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Acute Schizophrenia, Schizoaffective Disorder
What is being tested?: RP5063 and aripiprazole
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 234 participants
Where: 15 sitesin 5 countries
Study dates: Dec 2011to Mar 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients providing informed consent prior to any study specific procedures
Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder
Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)

Who cannot join

Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder

Trial locations and contacts

15 sites in 5 countries.

Country

City, postcode or hospital

15 sites in 5 countries

India7 sites

Reviva site
Bangalore
Reviva site
Chennai
Reviva site
Guntur
Reviva site
Jaipur
Reviva site
Kanpur
Reviva site
Lucknow
Reviva site
Mangalore

Other trials in India

Malaysia3 sites

Reviva site
Johor Bahru
Reviva site
Kuala Lumpur
Reviva Site
Tanjung Rambutan

Other trials in Malaysia

Philippines3 sites

Reviva site
Mandaluyong
Reviva site
Mandurriao
Reviva site
Subandaku

Other trials in Philippines

United States1 site

Reviva site
Philadelphia, Pennsylvania, 19039

Other trials in United States

Moldova1 site

Reviva site
Chisinau

Other trials in Moldova

About this study

Official title: REFRESH : Randomized Double-blind, Placebo-controlled, Multicenter Trial to Assess the Safety and Efficacy of RP5063 in Subjects With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

Conditions: Acute Schizophrenia, Schizoaffective Disorder
Being tested: RP5063, placebo, aripiprazole
Medical subject headings: Psychotic Disorders

What participants receive

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

RP5063Drug
daily
placeboDrug
daily
aripiprazoleDrug
Also called Abilify
daily

Study groups in NCT01490086
Study group	Role	What they receive
15 mg RP5063 daily	Experimental	RP5063 15 mg once daily Receives: Drug: RP5063
30 mg RP5063 daily	Experimental	RP5063 30 mg once daily Receives: Drug: RP5063
50 mg RP5063 daily	Experimental	RP5063 50 mg once daily Receives: Drug: RP5063
Placebo	Placebo comparator	Placebo once daily Receives: Drug: placebo
aripiprazole	Active comparator	aripiprazole 15 mg daily Receives: Drug: aripiprazole

What is being measured

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

Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.
Measured: Baseline to Day 28

Secondary outcomes (4)

Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. Scores range from 1 (not ill at all) to 7 (among the most extremely ill). A reduction in score indicates an improvement in the subject's condition.
Measured: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
The Positive Scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility) and is calculated by adding the subscale item scores to obtain results ranging from 7 to 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Measured: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
The Negative Scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking) and is calculated by adding the negative subscale item scores to obtain results ranging from 7 to 49. Minimum score is 7, maximum score is 49. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Measured: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
The General Psychopathology Scale consists of 16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). The General Psychopathology score is obtained by adding the ratings of each item in the scale, with results ranging from 16 to 112. A higher score reflects worse outcome and a larger reduction in the score from baseline reflects better treatment efficacy.
Measured: Baseline to Day 28

Timeline

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

Dec 2011Mar 2013

First posted12 Dec 2011 (estimated)
Study startDec 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute SchizophreniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01490086
Sponsor's protocol ID: RVP-20-001
Acronym: REFRESH
Status last verified: Jul 2025
First submitted: 7 Dec 2011
Last updated: 8 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
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RecruitingPhase 3
Trial of Brexpiprazole Once-weekly (QW) Formulation in Patients With Acute Schizophrenia
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All Acute Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REFRESH : Randomized Double-blind, Placebo-controlled, Multicenter Trial to Assess the Safety and Efficacy of RP5063 in Subjects With an Acute Exacerbation of Schizophrenia or Schizoaffective Disorder
ClinicalTrials.gov ID: NCT01490086
Acronym / sponsor ID: REFRESH / RVP-20-001
Conditions: Acute Schizophrenia, Schizoaffective Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Reviva PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Dec 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 12 Dec 2011 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of this study is to evaluate the efficacy and safety of RP5063 relative to placebo for the treatment of schizophrenia or schizoaffective disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
15 mg RP5063 daily	Experimental	Drug: RP5063RP5063 15 mg once daily
30 mg RP5063 daily	Experimental	Drug: RP5063RP5063 30 mg once daily
50 mg RP5063 daily	Experimental	Drug: RP5063RP5063 50 mg once daily
Placebo	Placebo comparator	Drug: placeboPlacebo once daily
aripiprazole	Active comparator	Drug: aripiprazolearipiprazole 15 mg daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients providing informed consent prior to any study specific procedures
Patients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), or schizoaffective disorder
Patients with normal physical examination, laboratory, vital signs,and electrocardiogram (ECG)

Key exclusion criteria (1 listed)

Patients with other primary psychiatric disorders as delirium, or bipolar I or II disorder

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RP5063daily	Drug	15 mg RP5063 daily, 30 mg RP5063 daily, 50 mg RP5063 daily
placebodaily	Drug	Placebo
aripiprazoleAlso: Abilifydaily	Drug	aripiprazole

Primary outcome

Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline to Day 28
PANSS total score comprises Positive (Delusions, Conceptual disorganization, Hallucinatory behavior, Excitement, Grandiosity, Suspiciousness/persecution, Hostility), Negative (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking), and General Psychopathology (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance) Scales. Scores are obtained by adding the ratings of each item in each scale. Range is 7-49 for Positive and Negative scores; 16-112 for General Psychopathology score; and 30-210 for Total score. Higher score reflects worse outcome; larger reduction from baseline reflects better outcome.

4 secondary outcomes

Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the Clinical Global Impression Scale - Severity (CGI-S)
Time frame: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Positive Subscale
Time frame: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS Negative Subscale
Time frame: Baseline to Day 28
Demonstrates Antipsychotic Efficacy as Assessed by Change From Baseline on the PANSS General Psychopathology Subscale
Time frame: Baseline to Day 28

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RP5063 15 mg	58	50
RP5063 30 mg	59	44
RP5063 50 mg	58	51
Aripiprazole 15 mg	20	13
Placebo	39	28

Primary outcome: Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score

Time frame: Baseline to Day 28. Mean (Standard Deviation). Unit: scores on a scale

Measure	RP5063 15 mg n = 56	RP5063 30 mg n = 57	RP5063 50 mg n = 57	Aripiprazole 15 mg n = 19	Placebo n = 37
Baseline	87.57 (13.30)	88.74 (13.37)	85.88 (14.86)	91.68 (16.10)	89.84 (15.60)
Day 28	67.34 (21.98)	73.32 (20.24)	66.67 (19.66)	82.37 (22.13)	78.43 (24.14)

Population analysed: The ITT population is comprised of participants who had received at least one dose of treatment, have baseline and at least one assessment of PANSS and CGI-S without major deviations at baseline.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over a period of 14 months.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RP5063 15 mg	1 of 58 (1.7%)	29 of 58 (50%)	Not reported
RP5063 30 mg	1 of 59 (1.7%)	30 of 59 (50.8%)	Not reported
RP5063 50 mg	1 of 58 (1.7%)	37 of 58 (63.8%)	Not reported
Aripiprazole 15 mg	2 of 20 (10%)	10 of 20 (50%)	Not reported
Placebo	0 of 38 (0%)	23 of 38 (60.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Schizophrenia

Not yet recruitingPhase 3
Phase 3 Study of HS-10380 for Acute Schizophrenia in Chinese Adults
SCHIZOPHRENIA 1 (Disorder)
Recruiting
A Closed Unit Incorporating Soteria Elements Versus a Conventional Closed Psychiatric Ward
Psychotic Disorders
Recruiting
FEEL-GOOD: A Multicenter Trial of a Mindfulness-Based Group Therapy in Young Adults With Early Psychosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

M Cantillon study director

Fundacion REVIVA, Red de VIH del Valle del Cauca

15 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RP5063 and aripiprazole in people with Acute Schizophrenia and Schizoaffective Disorder, run by Reviva Pharmaceuticals at 15 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in India, Malaysia, Philippines, United States, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). 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?

Measurement of Schizophrenia Symptoms: Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline to Day 28). 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 NCT01490086.

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 8 Aug 2025.