SchizophreniaPhase 2NCT00839852

A Study of Cariprazine in Patients With Chronic Stable Schizophrenia

A Phase 2 study testing Cariprazine in people with Schizophrenia, run by Forest Laboratories at 65 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

This is an outpatient study 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 61 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: 97 participants
Where: 65 sitesin 5 countries
Study dates: 31 May 2009to 31 Aug 2010
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 61 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
Patients must have a caregiver to ensure treatment compliance.

Who cannot join

Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

Trial locations and contacts

65 sites in 5 countries.

Country

City, postcode or hospital

65 sites in 5 countries

Russia18 sites

Forest Investigative Site
Arkhangelsk, 163060
Forest Investigative Site
Gatchina, 188357
Forest Investigative Site
Ivanovo, 153462
Forest Investigative Site
Kazan', 420012
Forest Investigative Site
Krasnodar, 350007
Forest Investigative Site 204
Moscow, 115522
Forest Investigative Site 206
Moscow, 115522
Forest Investigative Site
Moscow, 117152
Forest Investigative Site
Nizhny Novgorod, 603155
Forest Investigative Site 214
Saint Petersburg, 190005
Forest Investigative Site 217
Saint Petersburg, 190005
Forest Investigative Site
Saint Petersburg, 190121
Forest Investigative Site
Saint Petersburg, 191119
Forest Investigative Site 202
Saint Petersburg, 193019
Forest Investigative Site 203
Saint Petersburg, 193019
Forest Investigative Site
Saint Petersburg, 193167
Forest Investigative Site
Saint Petersburg, 197341
Forest Investigative Site
Samara, 443016

Other trials in Russia

United States17 sites

Forest Investigative Site
Baltimore, Maryland, 21202
Forest Investigative Site
Bradenton, Florida, 34208
Forest Investigative Site
Charleston, South Carolina, 29405
Forest Investigative Site
Cincinnati, Ohio, 45267
Forest Investigative Site
Costa Mesa, California, 92626
Forest Investigative Site
Creve Coeur, Missouri, 63141
Forest Investigative Site
Flowood, Mississippi, 39232
Forest Investigative Site
Houston, Texas, 77008
Forest Investigative Site
Irving, Texas, 75062
Forest Investigative Site
Kissimmee, Florida, 34741
Forest Investigative Site
Lake Charles, Louisiana, 70601
Forest Investigative Site
Long Beach, California, 90813
Forest Investigative Site
Memphis, Tennessee, 38119
Forest Investigative Site
Oceanside, California, 92056
Forest Investigative Site
Paramount, California, 90723
Forest Investigative Site
Riverside, California, 92506
Forest Investigative Site
Washington D.C., District of Columbia, 20016

Other trials in United States

India16 sites

Forest Investigative Site
Ahmedabad, Gujarat, 380013
Forest Investigative Site
Ahmedabad, Gujarat, 380015
Forest Investigative Site
Bangalore, Karna, 560010
Forest Investigative Site
Bangalore, Karna, 560027
Forest Investigative Site
Chennai, Tamil Nadu, 600003
Forest Investigative Site
Chennai, Tamil Nadu, 600101
Forest Investigative Site
Jaipur, Rajasthan, 302021
Forest Investigative Site
Kanpur, Uttar Prad, 208005
Forest Investigative Site
Mangalore, Karna, 574160
Forest Investigative Site
Mangalore, Karna, 575001
Forest Investigative Site
Manipal, Karna, 576104
Forest Investigative Site
Mysore, Karna, 570004
Forest Investigative Site
Pune, Mahara, 411004
Forest Investigative Site
Tirupati, Tamil Nadu, 517507
Forest Investigative Site
Vijaywada, Andh Prad, 520002
Forest Investigative Site
Visakhapatnam, Andh Prad, 530017

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Ukraine11 sites

Forest Investigative Site
Chernihiv, 14000
Forest Investigative Site
Dnipropetrovsk, 49616
Forest Investigative Site
Donetsk, 83037
Forest Investigative Site
Hlevakha, 8630
Forest Investivative Site
Kharkiv, 61068
Forest Investigative Site
Kherson, Vil. Stepanivka, 73488
Forest Investigative Site
Kiev, 2660
Forest Investigative Site
Kyiv, 4080
Forest Investigative Site
Kyiv, 4655
Forest Investigative Site
Odesa, 65006
Forest Investigative Site
Ternopil, 46020

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Malaysia3 sites

Forest Investigative Site
Johor Bahru, 80100
Forest Investigative Site
Kuala Lumpur, 59100
Forest Investigative Site
Perak, 30990

Other trials in Malaysia

About this study

Official title: A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Conditions: Schizophrenia
Being tested: Cariprazine
Medical subject headings: Schizophrenia

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 NCT00839852
Study group	Role	What they receive
Cariprazine 1.5mg	Experimental	Participants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability Receives: Drug: Cariprazine

What is being measured

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

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)

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.

31 May 200931 Aug 2010

First posted10 Feb 2009 (estimated)
Study start31 May 2009
Primary completion31 Aug 2010
Study completion31 Aug 2010

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 (3)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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 97 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839852
Sponsor's protocol ID: RGH-MD-17
Status last verified: Aug 2019
First submitted: 5 Feb 2009
Last updated: 22 Aug 2019
Results posted: Yes, on ClinicalTrials.gov

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

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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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT00839852
Acronym / sponsor ID: RGH-MD-17
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 97 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Collaborators: Gedeon Richter Ltd.
Study start: 31 May 2009 (actual)
Primary completion: 31 Aug 2010 (actual)
Study completion: 31 Aug 2010 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 22 Aug 2019

Clinical summary

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

This is an outpatient study to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cariprazine 1.5mg	Experimental	Drug: CariprazineParticipants received cariprazine 1.5 mg capsule once, twice or three times a day depending on their response and tolerability

Who may qualify

Ages: 18 to 61 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients who have completed the double-blind treatment period of the lead-in study RGH-MD-16 (NCT 00694707)
Patients who have responded to double-blind treatment in the lead-in study as defined as ≥ 20% reduction relative to Visit 2 (Baseline) of the Positive and Negative Syndrome Scale (PANSS) total score and a Clinical Global Impressions-Severity (CGI-S) score of ≤ 3.
Patients eligible to continue as outpatients based on the opinion of the Principal Investigator.
Patients must have a caregiver to ensure treatment compliance.

Key exclusion criteria (1 listed)

Patients with clinically significant abnormalities on physical examination, laboratory, vital signs, and/or electrocardiogram (ECG).

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-188Cariprazine was supplied in capsules.	Drug	Cariprazine 1.5mg

Primary outcome

Change From Baseline to Week 48 in the PANSS Total Score
Time frame: Baseline to Week 48
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.

1 secondary outcome

Change From Baseline to Week 48 in the CGI-S Score
Time frame: Baseline to Week 48

Results and safety

Results posted to the registry on 22 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cariprazine	93	46

Primary outcome: Change From Baseline to Week 48 in the PANSS Total Score

Time frame: Baseline to Week 48. Mean (Standard Error). Unit: Units on a scale

Measure	Cariprazine n = 92
Value	-38.5 (1.5)

Population analysed: Intent-to-treat population: All participants who took at least 1 dose of cariprazine and who had at least 1 post-baseline assessment of the PANSS total score.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to Week 52. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cariprazine	12 of 93 (12.9%)	62 of 93 (66.7%)	0 of 93

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
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 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.

Related trials for Schizophrenia

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A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
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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.

Suresh Durgam, MD study director

Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

65 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 Cariprazine in people with Schizophrenia, run by Forest Laboratories at 65 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 4 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Russia, United States, India, Ukraine, Malaysia. 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 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 22 Aug 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 NCT00839852, 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 22 Aug 2019.