SchizophreniaPhase 3NCT01104779

Safety and Efficacy of Cariprazine in Schizophrenia

A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 41 sites in 4 countries.

Completed

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

Official record

Search all trials

Trial summary

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation 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?: Cariprazine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 446 participants
Where: 41 sitesin 4 countries
Study dates: 27 Apr 2010to 15 Dec 2011
Phase: Phase 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

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the 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), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Who cannot join

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
Substance abuse or dependence within the prior 3 months

Trial locations and contacts

41 sites in 4 countries.

Country

City, postcode or hospital

41 sites in 4 countries

India19 sites

Forest Investigative Site 503
Ahmedabad, Gujarat, 380006
Forest Investigative Site 519
Ahmedabad, Gujarat, 380006
Forest Investigative Site 501
Ahmedabad, Gujarat, 380013
Forest Investigative Site 508
Ahmedabad, Gujarat, 380015
Forest Investigative Site 504
Bangalore, Karna, 560010
Forest Investigative Site 500
Chhatrapati Sambhajinagar, Mahara, 431005
Forest Investigative Site 507
Kanpur, Uttar Pradesh, 208005
Forest Investigative Site 518
Lucknow, Uttar Pradesh, 226006
Forest Investigative Site 517
Mangalore, Karna, 575001
Forest Investigative Site 515
Mangalore, Karna, 575018
Forest Investigative Site 510
Mumbai, Mahara, 400026
Forest Investigative Site 516
Mysore, Karna, 570015
Forest Investigative Site 513
Nashik, Mahara, 422101
Forest Investigative Site 511
Pune, Mahara, 411001
Forest Investigative Site 502
Pune, Mahara, 411030
Forest Investigative Site 509
Rajkot, Rajasthan, 360002
Forest Investigative Site 506
Varanasi, Uttar Pradesh, 201010
Forest Investigative Site 505
Vijayawada, Andhra Pradesh, 520002
Forest Investigative Site 514
Visakhapatnam, Andhra Pradesh, 530017

Other trials in India

United States15 sites

Forest Investigative Site 055
Atlanta, Georgia, 30308
Forest Investigative Site 40
Cedarhurst, New York, 11516
Forest Investigative Site 46
Cincinnati, Ohio, 45219
Forest Investigative Site 48
Costa Mesa, California, 92626
Forest Investigative Site 51
Houston, Texas, 77021
Forest Investigative Site 43
Irving, Texas, 75062
Forest Investigative Site 41
Kissimmee, Florida, 34741
Forest Investigative Site 52
Las Vegas, Nevada, 89102
Forest Investigative Site 50
Long Beach, California, 90813
Forest Investigative 49
Memphis, Tennessee, 38119
Forest Investigative Site 42
Paramount, California, 90723
Forest Investigative Site 47
Philadelphia, Pennsylvania, 19139
Forest Investigative Site 44
Rockville, Maryland, 20850
Forest Investigative Site 054
San Diego, California, 92102
Forest Investigative Site 45
St Louis, Missouri, 63118

Other trials in United States

Colombia4 sites

Forest Investigative Site 601
Bello, Antioquia, 051053
Forest Investigative Site 602
Bogotá, 110121
Forest Investigative Site 605
Bogotá, 111166
Forest Investigative Site 604
Pereira, Risaralda Department, 660003

Other trials in Colombia

South Africa3 sites

Forest Investigative Site 703
Cape Town, W Cape, 7530
Forest Investigative Site 706
Cape Town, W Cape, 7535
Forest Investigative Site 704
Johannesburg, Gauteng, 2198

Other trials in South Africa

About this study

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Conditions: Schizophrenia
Being tested: Cariprazine, Placebo
Keywords: Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents
Medical subject headings: Schizophrenia, Mental Disorders

What participants receive

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

CariprazineDrug
Also called RGH-188
Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
PlaceboDrug
Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.

Study groups in NCT01104779
Study group	Role	What they receive
Cariprazine (3-6 mg/day)	Experimental	Cariprazine once daily fixed-flexible low dose Receives: Drug: Cariprazine
Cariprazine (6-9 mg/day)	Experimental	Cariprazine once daily fixed-flexible high dose Receives: Drug: Cariprazine
Placebo	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

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

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.
Measured: Baseline to Week 6

Secondary outcomes (1)

Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
The Clinical Global Impressions-Severity scale is a clinician-rated scale that measures the overall severity of a participant's illness in comparison with the severity of illness in other participants the physician has observed. The participant is rated on a scale from 1 to 7 with 1 indicating a "normal state" and 7 indicating "among the most extremely ill participants." A higher score indicates greater illness. A negative change score indicates improvement.
Measured: Baseline to Week 6

Timeline

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

27 Apr 201015 Dec 2011

First posted15 Apr 2010 (estimated)
Study start27 Apr 2010
Primary completion15 Dec 2011
Study completion15 Dec 2011

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.
Publications (6)Papers the sponsor has linked to this study.
Other trials for 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 446 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01104779
Sponsor's protocol ID: RGH-MD-05
Status last verified: Oct 2018
First submitted: 14 Apr 2010
Last updated: 14 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
PubMed 34091867
Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.
PubMed 33854317
Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.
PubMed 30470662
Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
PubMed 28692485
Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.
PubMed 28478771
Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.
PubMed 26845266

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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Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
ClinicalTrials.gov ID: NCT01104779
Acronym / sponsor ID: RGH-MD-05
Conditions: Schizophrenia
Keywords: Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 446 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: 27 Apr 2010 (actual)
Primary completion: 15 Dec 2011 (actual)
Study completion: 15 Dec 2011 (actual)
First posted: 15 Apr 2010 (estimated)
Results: Posted 14 Nov 2018

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, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cariprazine (3-6 mg/day)	Experimental	Drug: CariprazineCariprazine once daily fixed-flexible low dose
Cariprazine (6-9 mg/day)	Experimental	Drug: CariprazineCariprazine once daily fixed-flexible high dose
Placebo	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Patients who have provided informed consent prior to any study specific procedures
Patients currently meeting the 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), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Key exclusion criteria (6 listed)

Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
Patients in their first episode of psychosis
Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study

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
CariprazineAlso: RGH-188Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug	Cariprazine (3-6 mg/day), Cariprazine (6-9 mg/day)
PlaceboPatients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.	Drug	Placebo

Primary outcome

Measurement of Schizophrenia Symptoms: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Baseline to Week 6
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a composite index, and general psychopathology. Each item is scored on a 7-point (1 to 7) scale, with 1 being minimal impact, and 7 being highest impact. The cumulative score ranges from 30 to 210. A negative change score indicates improvement.

1 secondary outcome

Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Week 6

Results and safety

Results posted to the registry on 14 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	147	88
Cariprazine (3-6 mg/Day)	151	96
Cariprazine (6-9 mg/Day)	148	86

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

Time frame: Baseline to Week 6. Least squares mean (Standard Error). Unit: Units on a Scale

Measure	Placebo n = 145	Cariprazine (3-6 mg/Day) n = 147	Cariprazine (6-9 mg/Day) n = 147
Value	-16.0 (1.6)	-22.8 (1.6)	-25.9 (1.7)

Placebo vs Cariprazine (3-6 mg/Day): Mean Difference (Final Values): -6.8 (95% CI -11.3 to -2.4), p = 0.0029, ANCOVA
Placebo vs Cariprazine (6-9 mg/Day): Mean Difference (Final Values): -9.9 (95% CI -14.5 to -5.3), p <0.0001, ANCOVA

Population analysed: Intent-to-Treat Population, consisting of all patients in the Safety Population who had at least one postbaseline assessment of the PANSS total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse Events were collected for 8 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	13 of 161 (8.1%)	54 of 147 (36.7%)	0 of 147
Cariprazine (3-6 mg/Day)	9 of 167 (5.4%)	84 of 151 (55.6%)	0 of 151
Cariprazine (6-9 mg/Day)	4 of 169 (2.4%)	86 of 148 (58.1%)	0 of 148

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34091867Laszlovszky I, Barabassy A, Nemeth G. Cariprazine, A Broad-Spectrum Antipsychotic for the Treatment of Schizophrenia: Pharmacology, Efficacy, and Safety. Adv Ther. 2021 Jul;38(7):3652-3673. doi: 10.1007/s12325-021-01797-5. Epub 2021 Jun 6.
Derived from this study: PubMed 33854317Barabassy A, Sebe B, Acsai K, Laszlovszky I, Szatmari B, Earley WR, Nemeth G. Safety and Tolerability of Cariprazine in Patients with Schizophrenia: A Pooled Analysis of Eight Phase II/III Studies. Neuropsychiatr Dis Treat. 2021 Apr 7;17:957-970. doi: 10.2147/NDT.S301225. eCollection 2021.
Derived from this study: PubMed 30470662Marder S, Fleischhacker WW, Earley W, Lu K, Zhong Y, Nemeth G, Laszlovszky I, Szalai E, Durgam S. Efficacy of cariprazine across symptom domains in patients with acute exacerbation of schizophrenia: Pooled analyses from 3 phase II/III studies. Eur Neuropsychopharmacol. 2019 Jan;29(1):127-136. doi: 10.1016/j.euroneuro.2018.10.008. Epub 2018 Nov 20.
Derived from this study: PubMed 28692485Earley W, Durgam S, Lu K, Laszlovszky I, Debelle M, Kane JM. Safety and tolerability of cariprazine in patients with acute exacerbation of schizophrenia: a pooled analysis of four phase II/III randomized, double-blind, placebo-controlled studies. Int Clin Psychopharmacol. 2017 Nov;32(6):319-328. doi: 10.1097/YIC.0000000000000187.
Derived from this study: PubMed 28478771Cutler AJ, Durgam S, Wang Y, Migliore R, Lu K, Laszlovszky I, Nemeth G. Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.
Derived from this study: PubMed 26845266Citrome L, Durgam S, Lu K, Ferguson P, Laszlovszky I. The effect of cariprazine on hostility associated with schizophrenia: post hoc analyses from 3 randomized controlled trials. J Clin Psychiatry. 2016 Jan;77(1):109-15. doi: 10.4088/JCP.15m10192.

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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.

Raffaele Migliore, MA study director

Forest Laboratories

41 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 41 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 5 inclusion and 6 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 14 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in India, United States, Colombia, South Africa. 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 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 14 Nov 2018). 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: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score (time frame: Baseline to Week 6). 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 NCT01104779, which also lists 6 linked publications.

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 14 Nov 2018.