Clinical trial NCT00839852: A Study of Cariprazine in Patients With Chronic Stable Schizophrenia
Official title: A Long-term, Open-label Extension Study of the Safety and Tolerability of RGH-188 (Cariprazine) in Patients With 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: 2009-02-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Change From Baseline to Week 48 in the PANSS Total Score
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Change From Baseline to Week 48 in the CGI-S Score
timeFrame: Baseline to Week 48
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: Creve Coeur
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: 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
city: Kuala Lumpur
country: Malaysia
facility: Forest Investigative Site
city: Perak
country: Malaysia
facility: Forest Investigative Site
city: Arkhangelsk
country: Russian Federation
facility: Forest Investigative Site
city: Gatchina
country: Russian Federation
facility: Forest Investigative Site
city: Ivanovo
country: Russian Federation
facility: Forest Investigative Site
city: Kazan
country: Russian Federation
facility: Forest Investigative Site
city: Krasnodar
country: Russian Federation
facility: Forest Investigative Site
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 204
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 206
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 214
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 217
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 202
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 203
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site
city: Kherson
country: Ukraine
facility: Forest Investigative Site
state: Vil. Stepanivka
city: Chernigov
country: Ukraine
facility: Forest Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site
city: Donetsk
country: Ukraine
facility: Forest Investigative Site
city: Glevakha
country: Ukraine
facility: Forest Investigative Site
city: Kharkiv
country: Ukraine
facility: Forest Investivative Site
city: Kiev
country: Ukraine
facility: Forest Investigative Site
city: Kyiv
country: Ukraine
facility: Forest Investigative Site
city: Kyiv
country: Ukraine
facility: Forest Investigative Site
city: Odessa
country: Ukraine
facility: Forest Investigative Site
city: Ternopil
country: Ukraine
facility: Forest Investigative Site
Study officials:
affiliation: Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
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: 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.