Clinical trial NCT00694707: Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Official title: Evaluation of the Safety and Efficacy of RGH-188 in the Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
Collaborators: name: Gedeon Richter Ltd.
First posted: 2008-06-10
Enrollment: 732
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188) relative to placebo in adult patients (18-60 years of age) with acute exacerbation of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Male or female, 18 to 60 years of age.
* Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).
* Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.
* Diagnosis of schizophrenia for at least 1 year.

Exclusion Criteria:

* Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or clinical laboratory values.
* First episode of psychosis.

Primary outcomes:
measure: Change From Baseline to Week 6 in the PANSS Total Score
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: Change From Baseline to Week 6 in the CGI-S Score
timeFrame: Baseline to Week 6
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Forest Investigative Site
state: California
city: Long Beach
country: United States
facility: Forest Investigative Site
state: California
city: Oceanside
country: United States
facility: Forest Investigative Site
state: California
city: Paramount
country: United States
facility: Forest Investigative Site
state: California
city: Riverside
country: United States
facility: Forest Investigative Site
state: California
city: Washington
country: United States
facility: Forest Investigative Site
state: District of Columbia
city: Bradenton
country: United States
facility: Forest Investigative Site
state: Florida
city: Kissimmee
country: United States
facility: Forest Investigative Site
state: Florida
city: Lake Charles
country: United States
facility: Forest Investigative Site
state: Louisiana
city: Baltimore
country: United States
facility: Forest Investigative Site
state: Maryland
city: Flowood
country: United States
facility: Forest Investigative Site
state: Mississippi
city: Bridgeton
country: United States
facility: Forest Investigative Site
state: Missouri
city: Cincinnati
country: United States
facility: Forest Investigative Site
state: Ohio
city: Charleston
country: United States
facility: Forest Investigative Site
state: South Carolina
city: Memphis
country: United States
facility: Forest Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site
state: Texas
city: Irving
country: United States
facility: Forest Investigative Site
state: Texas
city: Vijaywada
country: India
facility: Forest Investigative Site
state: Andh Prad
city: Visakhapatnam
country: India
facility: Forest Investigative Site
state: Andh Prad
city: Ahmedabad
country: India
facility: Forest Investigative Site
state: Gujarat
city: Ahmedabad
country: India
facility: Forest Investigative Site
state: Gujarat
city: Bangalore
country: India
facility: Forest Investigative Site
state: Karna
city: Bangalore
country: India
facility: Forest Investigative Site
state: Karna
city: Mangalore
country: India
facility: Forest Investigative Site
state: Karna
city: Mangalore
country: India
facility: Forest Investigative Site
state: Karna
city: Manipal
country: India
facility: Forest Investigative Site
state: Karna
city: Mysore
country: India
facility: Forest Investigative Site
state: Karna
city: Pune
country: India
facility: Forest Investigative Site
state: Mahara
city: Jaipur
country: India
facility: Forest Investigative Site
state: Rajasthan
city: Chennai
country: India
facility: Forest Investigative Site
state: Tamilnadu
city: Chennai
country: India
facility: Forest Investigative Site
state: Tamilnadu
city: Tirupati
country: India
facility: Forest Investigative Site
state: Tamilnadu
city: Kanpur
country: India
facility: Forest Investigative Site
state: Uttar Prad
city: Johor Bahru
country: Malaysia
facility: Forest Investigative Site
state: Johor
city: Kota Bharu
country: Malaysia
facility: Forest Investigative Site
state: Kelantan
city: Lembah Pantai
country: Malaysia
facility: Forest Investigative Site
state: Kuala Lumpur
city: Ipoh
country: Malaysia
facility: Forest Investigative Site
state: Perak
city: Ulu Kinta
country: Malaysia
facility: Forest Investigative Site
state: Perak
city: Arkhangelsk
country: Russian Federation
facility: Forest Investigative Site
city: Gatchina
country: Russian Federation
facility: Forest Investigative Site
city: Kazan
country: Russian Federation
facility: Forest Investigative Site
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 1
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 2
city: Moscow
country: Russian Federation
facility: Forest Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Forest Investigative Site
city: Samara
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 2
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site1
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site
state: Dnipropetrovsk Oblast
city: Donetsk
country: Ukraine
facility: Forest Investigative Site
state: Donetsk Oblast
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site
state: Kharkiv Oblast
city: Glevakha
country: Ukraine
facility: Forest Investigative Site
state: Kyiv Oblast
city: Kyiv
country: Ukraine
facility: Forest Investigative Site
state: Kyiv Oblast
city: Kyiv
country: Ukraine
facility: Forest Investigative Site
state: Kyiv Oblast
city: Odessa
country: Ukraine
facility: Forest Investigative Site
state: Odessa Oblast
city: Ternopil
country: Ukraine
facility: Forest Investigative Site
state: Ternopil Oblast
city: Chernigiv
country: Ukraine
facility: Forest Investigative Site
city: Kherson, Vil. Stepanivka
country: Ukraine
facility: Forest Investigative Site
city: Kiev
country: Ukraine
facility: Forest Investigative Site
Study officials:
affiliation: Forest Laboratories
name: Suresh Durgam, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Durgam S, Starace A, Li D, Migliore R, Ruth A, Nemeth G, Laszlovszky I. An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: a phase II, randomized clinical trial. Schizophr Res. 2014 Feb;152(2-3):450-7. doi: 10.1016/j.schres.2013.11.041. Epub 2014 Jan 10.