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SchizophreniaPhase 3NCT01104792

Long-term Study of Cariprazine in Patients With Schizophrenia

A Phase 3 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 86 sites in 6 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 long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with 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?
No, everyone receives an active treatment
How many people
752 participants
Where
86 sitesin 6 countries
Study dates
31 May 2010to 31 Jan 2013
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 and corresponding caregivers who have provided informed consents 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 electrocardiogram (ECG).

Who cannot join

  • Patients with a DSM-IV-TR diagnosis of schizoaffective disorder, schizophreniform disorder, bipolar I or bipolar II disorder, or psychotic disorders other than schizophrenia.

Trial locations and contacts

86 sites in 6 countries.

86 sites in 6 countries

United States39 sites

  • Forest Investigative Site 055

    Atlanta, Georgia, 30308

  • Forest Investigative Site 087

    Atlanta, Georgia, 30308

  • Forest Investigative Site 074

    Austin, Texas, 78756

  • Forest Investigative Site 078

    Bellevue, Washington, 98007

  • Forest Investigative Site 002

    Bradenton, Florida, 34208

  • Forest Investigative Site 080

    Carson, California, 90746

  • Forest Investigative Site 040

    Cedarhurst, New York, 11516

  • Forest Investigative Site 079

    Cerritos, California, 90703

  • Forest Investigative Site 018

    Chicago, Illinois, 60640

  • Forest Investigative Site 048

    Costa Mesa, California, 92626

  • Forest Investigative Site 070

    Costa Mesa, California, 92626

  • Forest Investigative Site 017

    Creve Coeur, Missouri, 63141

  • Forest Investigative Site 084

    DeSoto, Texas, 75115

  • Forest Investigative Site 007

    Flowood, Mississippi, 39232

  • Forest Investigative Site 022

    Garden Grove, California, 92845

  • Forest Investigative Site 083

    Garden Grove, California, 92845

  • Forest Investigative Site 008

    Hoffman Estates, Illinois, 60169

  • Forest Investigative Site 012

    Honolulu, Hawaii, 96813

  • Forest Investigative Site 043

    Irving, Texas, 75062

  • Forest Investigative Site 041

    Kissimmee, Florida, 34741

  • Forest Investigative Site 052

    Las Vegas, Nevada, 89102

  • Forest Investigative Site 072

    Little Rock, Arkansas, 72201

  • Forest Investigative Site 021

    Little Rock, Arkansas, 72211

  • Forest Investigative Site 086

    Little Rock, Arkansas, 72211

  • Forest Investigative Site 050

    Long Beach, California, 90813

  • Forest Investigative Site 071

    New Britain, Connecticut, 06050

  • Forest Investigative Site 082

    North Miami, Florida, 33161

  • Forest Investigative Site 006

    Oceanside, California, 92056

  • Forest Investigative Site 077

    Philadelphia, Pennsylvania, 19131

  • Forest Investigative Site 047

    Philadelphia, Pennsylvania, 19139

  • Forest Investigative Site 003

    Riverside, California, 92506

  • Forest Investigative Site 044

    Rockville, Maryland, 20850

  • Forest Investigative Site 076

    Saint Charles, Missouri, 63301

  • Forest Investigative Site 016

    San Diego, California, 92123

  • Forest Investigative Site 073

    Santa Ana, California, 92701

  • Forest Investigative Site 014

    Springdale, Arkansas, 72764

  • Forest Investigative Site 045

    St Louis, Missouri, 63118

  • Forest Investigative Site 004

    Willingboro, New Jersey, 08046

  • Forest Investigative Site 019

    Willoughby, Ohio, 44094

Other trials in United States

India13 sites

  • Forest Investigative Site 503

    Ahmedabad, 380006

  • Forest Investigative Site 519

    Ahmedabad, 380006

  • Forest Investigative Site 501

    Ahmedabad, 380013

  • Forest Investigative Site 500

    Chhatrapati Sambhajinagar, 431005

  • Forest Investigative Site 507

    Kanpur, 208005

  • Forest Investigative Site 518

    Lucknow, 226006

  • Forest Investigative Site 517

    Mangalore, 575001

  • Forest Investigative Site 515

    Mangalore, 575018

  • Forest Investigative Site 510

    Mumbai, 400026

  • Forest Investigative Site 513

    Nashik, 422101

  • Forest Investigative Site 509

    Rajkot, 360002

  • Forest Investigative Site 506

    Varanasi, 201010

  • Forest Investigative Site 505

    Vijaywada, 520002

Other trials in India

Russia12 sites

  • Forest Investigative Site 102

    Arkhangelsk, 163530

  • Forest Investigative Site 103

    Chelyabinsk, 454087

  • Forest Investigative Site 104

    Chita, 672090

  • Forest Investigative Site 112

    Saint Petersburg, 190121

  • Forest Investigative Site 105

    Saint Petersburg, 192019

  • Forest Investigative Site 106

    Saint Petersburg, 192019

  • Forest Investigative Site 113

    Saint Petersburg, 192019

  • Forest Investigative Site 107

    Saint Petersburg, 193167

  • Forest Investigative Site 109

    Saint Petersburg, 197341

  • Forest Investigative Site 110

    Saratov, 410028

  • Forest Investigative Site 108

    Saratov, 410060

  • Forest Investigative Site 100

    Tomsk, 634014

Other trials in Russia

Ukraine12 sites

  • Forest Investigative Site 208

    Dnipropetrovsk, 49005

  • Forest Investigative Site 205

    Dnipropetrovsk, 49027

  • Forest Investigative Site 200

    Donetsk, 83008

  • Forest Investigative Site 211

    Hlevakha, Kyiv Oblast, 08631

  • Forest Investigative Site 203

    Kharkiv, 61068

  • Forest Investigative Site 204

    Kharkiv, 61068

  • Forest Investigative Site 206

    Kherson, Stepanivka, 73488

  • Forest Investigative Site 201

    Kyiv, 04080

  • Forest Investigative Site 202

    Lviv, 79021

  • Forest Investigative Site 209

    Poltava, 36006

  • Forest Investigative Site 210

    Simferopol, 95006

  • Forest Investigative Site 207

    Vinnytsia, 21005

Other trials in Ukraine

Romania6 sites

  • Forest Investigative Site 306

    Bucharest, 41914

  • Forest Investigative Site 301

    Cluj-Napoca, 400012

  • Forest Investigative Site 300

    Craiova, 200620

  • Forest Investigative Site 311

    Craiova, 200745

  • Forest Investigative Site 303

    Targoviste, 130086

  • Forest Investigative Site 304

    Târgu Mureş, 540142

Other trials in Romania

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

About this study

Official title: Evaluation of the Long-term Safety, Tolerability, and Pharmacokinetics of Cariprazine in Patients With Schizophrenia

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Conditions
Schizophrenia
Being tested
Cariprazine
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

    Cariprazine was supplied in capsules.

Study groups in NCT01104792
Study groupRoleWhat they receive
CariprazineExperimentalParticipants received cariprazine 3.0, 4.5, 6.0, or 9.0 mg orally once a day for 48 weeks.
Receives: Drug: Cariprazine

What is being measured

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

  1. Change From Baseline to Week 48 in the PANSS Total Score

    The Positive and Negative Syndrome Scale (PANSS) is a 30-item rating scale that assesses the positive and negative symptoms of individuals with schizophrenia. Responses to the 30 items are based on a structured clinical interview with the patient and on supporting clinical information obtained from family, hospital staff, or other reliable informants. Of the 30 psychiatric parameters measured by the scale, 7 assess positive symptoms (eg, delusions, grandiosity); 7 assess negative symptoms (eg, blunted affect, emotional withdrawal); and 16 assess general psychopathology (eg, poor attention, active social avoidance). Each item is scored on a 7-point scale (1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderately severe, 6 = severe, and 7 = extreme). The PANSS total score can range from 30 to 210. A higher score indicates worse symptoms. A negative change score indicates improvement.

    Measured: Baseline to Week 48

Secondary outcomes (1)

  1. Change From Baseline to Week 48 in the CGI-S Score

    The Clinical Global Impressions-Severity (CGI-S) scale is a 7-point scale that measures the overall severity of the illness compared with the severity of illness in other patients the Investigator has observed. The Investigator assesses the severity of the patient's illness as one of the following: 1 = Normal, not at all ill; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients. The CGI-S score can range from 1 to 7. A higher score indicates more severe illness. A negative change score indicates improvement.

    Measured: Baseline to Week 48

Timeline

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

  1. First posted15 Apr 2010 (estimated)
  2. Study start31 May 2010
  3. Primary completion31 Jan 2013
  4. Study completion31 Jan 2013

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
752 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01104792
Sponsor's protocol ID
RGH-MD-11
Status last verified
Jul 2019
First submitted
12 Apr 2010
Last updated
26 Jul 2019
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

  • Nasrallah 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 28836957

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 86 sites in 6 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 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in United States, India, Russia, Ukraine, Romania and 1 more country. 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. 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 26 Jul 2019). 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 to Week 48 in the PANSS Total Score (time frame: Baseline to Week 48). 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 NCT01104792, which also lists 3 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 26 Jul 2019.

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