PMID- 27807604
OWN - NLM
STAT- MEDLINE
DCOM- 20171205
LR  - 20240324
IS  - 1432-2072 (Electronic)
IS  - 0033-3158 (Print)
IS  - 0033-3158 (Linking)
VI  - 234
IP  - 2
DP  - 2017 Jan
TI  - Safety and tolerability of cariprazine in the long-term treatment of 
      schizophrenia: results from a 48-week, single-arm, open-label extension study.
PG  - 199-209
LID - 10.1007/s00213-016-4450-3 [doi]
AB  - RATIONALE: Cariprazine, a dopamine D(3)/D(2) receptor partial agonist 
      antipsychotic, demonstrated efficacy and tolerability in 6-week, randomized, 
      placebo-controlled schizophrenia trials. Schizophrenia is a chronic disorder that 
      requires continuous treatment; therefore, the long-term safety and tolerability 
      profile of antipsychotic agents is an important factor in guiding clinician 
      decisions. OBJECTIVE: This single-arm, open-label extension study evaluated the 
      long-term safety and tolerability of cariprazine in patients with schizophrenia. 
      METHODS: Patients enrolled in this study completed a 6-week, randomized, placebo- 
      and active-controlled study and had responded (Clinical Global 
      Impressions-Severity [CGI-S] </=3; >/=20 % reduction in Positive and Negative 
      Syndrome Scale [PANSS] total score) to treatment at the end of the lead-in study. 
      Patients (N = 93) received flexibly dosed, open-label cariprazine 
      (1.5-4.5 mg/day) for up to 48 weeks. RESULTS: Approximately 50 % (46/93) of 
      patients completed the 48 weeks of open-label treatment. The most common adverse 
      events (AEs) were akathisia (14 %), insomnia (14 %), and weight increased (12 %). 
      Serious AEs (SAEs) occurred in 13 % of patients; 11 % discontinued due to AEs. 
      Mean changes in metabolic parameters were generally small and not clinically 
      relevant. Mean body weight increased by 1.9 kg from the start of the lead-in 
      study to the end of the extension study. There were no discontinuations 
      associated with change in metabolic parameters or body weight. Long-term 
      cariprazine treatment was not associated with prolactin elevation or clinically 
      significant changes in cardiovascular parameters. CONCLUSIONS: In this 48-week, 
      single-arm trial, open-label cariprazine (1.5-4.5 mg/day) treatment was generally 
      safe and well tolerated with no new safety concerns associated with long-term 
      treatment.
FAU - Durgam, Suresh
AU  - Durgam S
AD  - Allergan, Jersey City, NJ, USA. suresh.durgam@allergan.com.
FAU - Greenberg, William M
AU  - Greenberg WM
AD  - Allergan, Jersey City, NJ, USA.
FAU - Li, Dayong
AU  - Li D
AD  - Allergan, Jersey City, NJ, USA.
FAU - Lu, Kaifeng
AU  - Lu K
AD  - Allergan, Jersey City, NJ, USA.
FAU - Laszlovszky, Istvan
AU  - Laszlovszky I
AD  - Gedeon Richter Plc, Budapest, Hungary.
FAU - Nemeth, Gyorgy
AU  - Nemeth G
AD  - Gedeon Richter Plc, Budapest, Hungary.
FAU - Migliore, Raffaele
AU  - Migliore R
AD  - Allergan, Jersey City, NJ, USA.
FAU - Volk, Stephen
AU  - Volk S
AD  - Apostle Clinical Trials, Long Beach, CA, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161102
PL  - Germany
TA  - Psychopharmacology (Berl)
JT  - Psychopharmacology
JID - 7608025
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - F6RJL8B278 (cariprazine)
SB  - IM
MH  - Adult
MH  - Akathisia, Drug-Induced/diagnosis
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Schizophrenia/*diagnosis/*drug therapy
MH  - Time Factors
MH  - Treatment Outcome
MH  - Tremor/chemically induced/diagnosis
MH  - Weight Gain/drug effects
MH  - Young Adult
PMC - PMC5203812
OTO - NOTNLM
OT  - *Atypical antipsychotic
OT  - *Cariprazine
OT  - *Dopamine antagonist
OT  - *Open-label
OT  - *Safety
OT  - *Schizophrenia
COIS- Conflict of interestSuresh Durgam, William M. Greenberg, Dayong Li, Kaifeng Lu, 
      and Raffaele Migliore acknowledge a potential conflict of interest as current or 
      former employees of Allergan. Istvan Laszlovszky acknowledges a potential 
      conflict of interest as an employee of Gedeon Richter Plc. Stephen Volk has 
      received grant/research support from Eli Lilly, Forest Laboratories, Inc., Merck, 
      Otsuka Pharmaceuticals, and Sunovion Pharmaceuticals and is a stock shareholder 
      for MannKind Corporation and Arena Pharmaceuticals.Source of funding and material 
      supportThis work was supported by funding from Forest Research Institute, Inc., 
      an Allergan affiliate (Jersey City, New Jersey), and Gedeon Richter Plc. 
      (Budapest, Hungary). Forest Laboratories, LLC and Gedeon Richter Plc. were 
      involved in the study design, collection (via contracted clinical investigator 
      sites), analysis and interpretation of data, and the decision to present these 
      results. The authors have full control of all data and agree to allow the journal 
      to review the data if requested.
EDAT- 2016/11/04 06:00
MHDA- 2017/12/06 06:00
PMCR- 2016/11/02
CRDT- 2016/11/04 06:00
PHST- 2016/04/01 00:00 [received]
PHST- 2016/09/20 00:00 [accepted]
PHST- 2016/11/04 06:00 [pubmed]
PHST- 2017/12/06 06:00 [medline]
PHST- 2016/11/04 06:00 [entrez]
PHST- 2016/11/02 00:00 [pmc-release]
AID - 10.1007/s00213-016-4450-3 [pii]
AID - 4450 [pii]
AID - 10.1007/s00213-016-4450-3 [doi]
PST - ppublish
SO  - Psychopharmacology (Berl). 2017 Jan;234(2):199-209. doi: 
      10.1007/s00213-016-4450-3. Epub 2016 Nov 2.