SchizophreniaPhase 3NCT01104766
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
A Phase 3 study testing Cariprazine and Aripiprazole in people with Schizophrenia, run by Forest Laboratories at 58 sites in 4 countries.
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 and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 617 participants
- Where
- 58 sitesin 4 countries
- Study dates
- 23 Apr 2010to 20 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)
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
- Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
- CGI-S score ≥ 4
Who cannot join
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- Bipolar I and II disorder
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Women who are pregnant or breast feeding
Trial locations and contacts
58 sites in 4 countries.
58 sites in 4 countries
United States20 sites
Pacific Institute of Medical Sciences
Bothell, Washington, 98011
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Uptown Research Institute, LLC
Chicago, Illinois, 60640
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141
Synergy Clinical Research of Escondido
Escondido, California, 92025
Precise Research Centers
Flowood, Mississippi, 39232
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, 77008
Woodland International Research Group, Inc.
Little Rock, Arkansas, 72211
Colorado Clinical Trials, Inc.
Littleton, Colorado, 80130
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, 37212
Excell Research, Inc
Oceanside, California, 92056
Clinical Innovations, Inc.
Riverside, California, 92506
Sharp Mesa Vista Hospital
San Diego, California, 92123
Woodland Research Northwest, LLC
Springdale, Arkansas, 72764
Collaborative Neuroscience Network, Inc.
Torrance, California, 90502
Comprehensive Clinical Development, Inc.
Washington D.C., District of Columbia, 20016
CRI Worldwide, LLC
Willingboro, New Jersey, 08046
Windsor-Laurelwood Center for Behavioral Medicine
Willoughby, Ohio, 44094
Russia14 sites
State Healthcare Institution <Arkhangelsk Regional Clinical Psychiatric Hospital>
Arkhangelsk, 163530
State Healthcare Institution "Regional Clinical Specialized Psychoneurological Hospital #1"
Chelyabinsk, 454087
State Educational Institution of High Professional Education "Chita State Medical Academy of Roszdrav"
Chita, 672090
St. Petersburg State Healthcare Institution "Mental Hospital #1 named after P.P Kashchenko"
Gatchina, 188357
Healthcare Institution "Moscow Regional Mental Hospital #5"
Orekhovo-Zuyevo, Moscow Oblast, 142601
St. Petersburg State Healthcare Institution "St. Nicholas the Wonderworker Mental Hospital"
Saint Petersburg, 190121
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Ministry of Health and Social Development of the Russian Federation, Department of biological therapy of mental patients
Saint Petersburg, 192019
State institution "St. Petersburg scientifis-research psychoneurologic Institute of RosZdrav named after V.M Bekhterev"
Saint Petersburg, 192019
Federal State Budget Institution "St. Petersburg scientific-research psychoneurological Institute named after V.M Bekhterev" of the Minitstry of Health and Social Development of the Russian Federation
Saint Petersburg, 1922019
St. Petersburg State Healthcare Institution "City Mental Hospital #6 (hospital and Dispensary)"
Saint Petersburg, 193167
St. Petersburg State Healthcare Institution "City Mental Hospital #3 named after I.I Skvortsov-Stepanov", department #7
Saint Petersburg, 197341
Municipal Healthcare Institution "City Clinical Hospital #2 named after V.I Razumovsky"
Saratov, 410028
State Healthcare Institution "Saratov Saint Sophia Regional Mental Hospital"
Saratov, 410060
Regional State Healthcare Institution "Tomsk Clinical Mental Hospital"
Tomsk, 634014
Romania12 sites
Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Clinica X Psihiatrie
Bucharest, 041914
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica III Psihiatrie
Bucharest, 41914
Spitalul Clinic de Psihiatrie 'Prof. Dr. Alexandru Obregia', Clinica VIII Psihiatrie
Bucharest, 41914
Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Psihiatrie III
Cluj-Napoca, 400012
Spitalul Clinic de Neuropsihiatrie Craiova, Clinica II Psihiatrie
Craiova, 200620
Spitalul Clinic Militar de Urgenta, 'Dr. Stefan Odobleja' Clinical de Psihiatrie
Craiova, 200745
Spitalul Judetean de Urgenta Piatra Neamt
Piatra Neamţ, 610136
Spitalul Judetean de Urgenta Pitesti, Clinica de Psihiatrie
Piteşti, 110069
Spitalul de Psihiatrie Dr. Gheorghe Preda" Sibiu
Sibiu, 550082
Spitalul Judetean de Urgenta Targoviste, Sectia Psihiatrie
Targoviste, 130086
Spitalul Clinic Judetean Mures, Clinica Psihiatrie I
Târgu Mureş, 540142
Spitalul Clinic Judetean de Urgenta Timisoara, Sectia Clinica de Psihiatrie "eduard Pamfil"
Timișoara, 300736
Ukraine12 sites
I.I. Mecnikov Regional Clinical Hospital, Regional Center of Psychosomatic Pathology
Dnipropetrovsk, 49005
Ukraine State Scientific and Research Institute of Medical and Social Problems of Disabiolity, Department of Psychoneurology, Psychotherapy and Medical Psychology
Dnipropetrovsk, 49027
Regional Clinical Psychiatric Hospital Department #11, M. Gorkyy Donetsk National Medical University, Chair of Psychiatry and Medical Psychology
Donetsk, 83008
Kharkiv Regional Clinical Psychiatric Hospital #3, Department #4, Department #14
Kharkiv, 61068
State Institution: Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine, Department of Borderline Psychic Pathology
Kharkiv, 61068
Kherson Regional Psychiatric Hospital, Department #3
Kherson, 73488
Kyiv City Clinical Psychoneurological Hospital #1, Center of Novel Treatment Methods and Rehabilitation of Psychotic Conditions
Kyiv, 04080
Communal Institution: Lviv Regional Clinical Psychiatric Hospital, Department #3 (male), Department #10 (female)
Lviv, 79021
O.F. Maltsev Poltava Regional Clinical Psychiatric Hopspital, Department #3B, State Institution of Higher Education of Ukraine: Ukranian Medical Stomatological Academy, Chair of Psychiatry, Narcology and Medical Psychology
Poltava, 36006
Crimean Republican Institution: Clinical Psychiatric Hospital #1, Female Psychiatric Department #2, Male Psychiatric Department #1, S.I. Georgiyevskyy Crimean State Medical University, Chair of Psychiatry, Psychotherapy and Narcology
Simferopol, 95006
Communal Institution of Kyiv Regional Council: Regional Psychiatric-Narcological Medical Association, Department #2 and #14
Village Glevakha, Kyiv Oblast, 08613
O.I. Yuschenko Vinnytsya Regional Psychoneurological Hospital, Department #10, Department #14, M.I. Pyrogov Vinnytsya National Medical University, Chair of Psychiatry and Narcology
Vinnytsia, 49005
About this study
Official title: A Double-Blind, Placebo and Active-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, Aripiprazole, Placebo
- Keywords
- Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Aripiprazole, 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.
AripiprazoleDrug
Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole 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 group | Role | What they receive |
|---|---|---|
| Cariprazine 3mg | Experimental | 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. Receives: Drug: Cariprazine |
| Cariprazine 6mg | Experimental | 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. Receives: Drug: Cariprazine |
| Aripiprazole 10mg | Active comparator | Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. Receives: Drug: Aripiprazole |
| Placebo | Placebo comparator | 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. 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 from baseline score indicates improvement.
Measured: Baseline to Week 6
Secondary outcomes (1)
Measurement of the Overall Severity of Illness: 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 from baseline 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.
- First posted15 Apr 2010 (estimated)
- Study start23 Apr 2010
- Primary completion20 Dec 2011
- Study completion20 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 (8)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
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Responsible party
- Sponsor
- Investigators
- Raffaele Migliore, MA, Study director, Forest Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01104766
- Sponsor's protocol ID
- RGH-MD-04
- Status last verified
- Oct 2018
- First submitted
- 9 Apr 2010
- Last updated
- 29 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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 26845266Earley 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 28692485Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.
PubMed 28836957Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.
PubMed 26717533Laszlovszky 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 34091867Barabassy 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 33854317Marder 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 30470662Cutler 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo and Active-Controlled Evaluation of the Safety and Efficacy of Cariprazine in the Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT01104766
- Acronym / sponsor ID
- RGH-MD-04
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Acute Schizophrenia, Psychotropic Drugs, Aripiprazole, Antipsychotic Agents, Mental Disorders, Dopamine Agents, Central Nervous System Agents
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Gedeon Richter Ltd.
- Study start
- 23 Apr 2010 (actual)
- Primary completion
- 20 Dec 2011 (actual)
- Study completion
- 20 Dec 2011 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 29 Oct 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Cariprazine 3mg | Experimental | Drug: CariprazinePatients 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. |
| Cariprazine 6mg | Experimental | Drug: CariprazinePatients 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. |
| Aripiprazole 10mg | Active comparator | Drug: AripiprazolePatients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. |
| Placebo | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 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)
- Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)
- Current psychotic episode (schizophrenia exacerbation) < 2 weeks duration at Visit 1
- Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
Key exclusion criteria (5 listed)
- Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders
- Bipolar I and II disorder
- Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
- DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
- Women who are pregnant or breast feeding
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 3mg, Cariprazine 6mg |
| AripiprazolePatients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period. | Drug | Aripiprazole 10mg |
| 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 from baseline score indicates improvement.
1 secondary outcome
Measurement of the Overall Severity of Illness: Change From Baseline in Clinical Global Impression-Severity (CGI-S)
Time frame: Baseline to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: 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.
- Background: 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.
- Background: PubMed 28836957Nasrallah HA, Earley W, Cutler AJ, Wang Y, Lu K, Laszlovszky I, Nemeth G, Durgam S. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017 Aug 24;17(1):305. doi: 10.1186/s12888-017-1459-z.
- Results publication: PubMed 26717533Durgam S, Cutler AJ, Lu K, Migliore R, Ruth A, Laszlovszky I, Nemeth G, Meltzer HY. Cariprazine in acute exacerbation of schizophrenia: a fixed-dose, phase 3, randomized, double-blind, placebo- and active-controlled trial. J Clin Psychiatry. 2015 Dec;76(12):e1574-82. doi: 10.4088/JCP.15m09997.
- 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 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.
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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
58 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 and Aripiprazole in people with Schizophrenia, run by Forest Laboratories at 58 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 6 inclusion and 5 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 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Russia, Romania, Ukraine. 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 29 Oct 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 NCT01104766, which also lists 8 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 29 Oct 2018.