Safety and Efficacy of Cariprazine in Schizophrenia

NCT01104779 | Completed Phase 3 Results

• 1 other identifier: RGH-MD-05
• Study Type: interventional
• Target: 446
• Locations: 4 countries
• Sites: 41

Brief 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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Acute Schizophrenia; Psychotropic Drugs; Antipsychotic Agents; Mental Disorders; Dopamine Agents; Central Nervous System Agents

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Week 6

Secondary Outcomes (1)

• Measurement of Schizophrenia Symptoms: Change From Baseline in Clinical Global Impression-Severity (CGI-S)

  Baseline to Week 6

Study Arms (3)

Cariprazine (3-6 mg/day)

EXPERIMENTAL

Cariprazine once daily fixed-flexible low dose

Drug: Cariprazine

Cariprazine (6-9 mg/day)

EXPERIMENTAL

Cariprazine once daily fixed-flexible high dose

Drug: Cariprazine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cariprazine DRUG

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.

Also known as: RGH-188

Cariprazine (3-6 mg/day); Cariprazine (6-9 mg/day)

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Forest Laboratories: lead
• Gedeon Richter Ltd.: collaborator

Study Sites (41)

Forest Investigative Site 48

Costa Mesa, California, 92626, United States

Location

Forest Investigative Site 50

Long Beach, California, 90813, United States

Location

Forest Investigative Site 42

Paramount, California, 90723, United States

Location

Forest Investigative Site 054

San Diego, California, 92102, United States

Location

Forest Investigative Site 41

Kissimmee, Florida, 34741, United States

Location

Forest Investigative Site 055

Atlanta, Georgia, 30308, United States

Location

Forest Investigative Site 44

Rockville, Maryland, 20850, United States

Location

Forest Investigative Site 45

St Louis, Missouri, 63118, United States

Location

Forest Investigative Site 52

Las Vegas, Nevada, 89102, United States

Location

Forest Investigative Site 40

Cedarhurst, New York, 11516, United States

Location

Forest Investigative Site 46

Cincinnati, Ohio, 45219, United States

Location

Forest Investigative Site 47

Philadelphia, Pennsylvania, 19139, United States

Location

Forest Investigative 49

Memphis, Tennessee, 38119, United States

Location

Forest Investigative Site 51

Houston, Texas, 77021, United States

Location

Forest Investigative Site 43

Irving, Texas, 75062, United States

Location

Forest Investigative Site 601

Bello, Antioquia, 051053, Colombia

Location

Forest Investigative Site 604

Pereira, Risaralda Department, 660003, Colombia

Location

Forest Investigative Site 602

Bogotá, 110121, Colombia

Location

Forest Investigative Site 605

Bogotá, 111166, Colombia

Location

Forest Investigative Site 505

Vijayawada, Andhra Pradesh, 520002, India

Location

Forest Investigative Site 514

Visakhapatnam, Andhra Pradesh, 530017, India

Location

Forest Investigative Site 503

Ahmedabad, Gujarat, 380006, India

Location

Forest Investigative Site 519

Ahmedabad, Gujarat, 380006, India

Location

Forest Investigative Site 501

Ahmedabad, Gujarat, 380013, India

Location

Forest Investigative Site 508

Ahmedabad, Gujarat, 380015, India

Location

Forest Investigative Site 504

Bangalore, Karna, 560010, India

Location

Forest Investigative Site 517

Mangalore, Karna, 575001, India

Location

Forest Investigative Site 515

Mangalore, Karna, 575018, India

Location

Forest Investigative Site 516

Mysore, Karna, 570015, India

Location

Forest Investigative Site 500

Aurangabad, Mahara, 431005, India

Location

Forest Investigative Site 510

Mumbai, Mahara, 400026, India

Location

Forest Investigative Site 513

Nashik, Mahara, 422101, India

Location

Forest Investigative Site 511

Pune, Mahara, 411001, India

Location

Forest Investigative Site 502

Pune, Mahara, 411030, India

Location

Forest Investigative Site 509

Rajkot, Rajasthan, 360002, India

Location

Forest Investigative Site 507

Kanpur, Uttar Pradesh, 208005, India

Location

Forest Investigative Site 518

Lucknow, Uttar Pradesh, 226006, India

Location

Forest Investigative Site 506

Varanasi, Uttar Pradesh, 201010, India

Location

Forest Investigative Site 704

Johannesburg, Gauteng, 2198, South Africa

Location

Forest Investigative Site 703

Cape Town, W Cape, 7530, South Africa

Location

Forest Investigative Site 706

Cape Town, W Cape, 7535, South Africa

Location

Related Publications (6)

• 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.

  PMID: 34091867 DERIVED

• 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.

  PMID: 33854317 DERIVED

• 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.

  PMID: 30470662 DERIVED

• 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.

  PMID: 28692485 DERIVED

• 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.

  PMID: 28478771 DERIVED

• 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.

  PMID: 26845266 DERIVED

MeSH Terms

Conditions

Schizophrenia; Mental Disorders

Interventions

cariprazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Allergan

IR-CTRegistration@Allergan.com

877-277-8566

Study Officials

• Raffaele Migliore, MA

  Forest Laboratories

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2010
• First Posted: April 15, 2010
• Study Start: April 27, 2010
• Primary Completion: December 15, 2011
• Study Completion: December 15, 2011
• Last Updated: November 14, 2018
• Results First Posted: November 14, 2018

Record last verified: 2018-10

Locations

ZA (3); US (15); IN (19); CO (4)