PMID- 28843918
OWN - NLM
STAT- MEDLINE
DCOM- 20180413
LR  - 20181202
IS  - 1573-2517 (Electronic)
IS  - 0165-0327 (Linking)
VI  - 225
DP  - 2018 Jan 1
TI  - The safety and tolerability of cariprazine in patients with manic or mixed 
      episodes associated with bipolar I disorder: A 16-week open-label study.
PG  - 350-356
LID - S0165-0327(17)30241-0 [pii]
LID - 10.1016/j.jad.2017.08.040 [doi]
AB  - BACKGROUND: We evaluated the safety/tolerability of longer-term open-label 
      treatment with cariprazine in patients who had responded to cariprazine for acute 
      bipolar mania. METHODS: In this multinational, multicenter study, open-label, 
      flexible-dose, cariprazine 3-12mg/d was administered for up to 16 weeks to 
      patients (18-65 years) with bipolar mania. Safety evaluations included adverse 
      events (AEs), laboratory values, vital signs, and extrapyramidal symptom (EPS) 
      scales. Symptom change was evaluated by Young Mania Rating Scale (YMRS) total 
      score change from baseline using the last observation carried forward approach. 
      RESULTS: Of the 402 patients taking cariprazine, 33% completed the trial; the 
      most frequent reasons for discontinuation were withdrawal of consent (20%), AEs 
      (16%), and protocol violation (14%). Most common AEs leading to discontinuation 
      were akathisia (4.7%) and depression (1.5%). Mean treatment duration was 57.7 
      days; mean cariprazine dose was 6.2mg/d. The incidence of serious AEs was 7.5% 
      (most common: mania [2.2%], depression [1.2%]); 83.3% had treatment-emergent AEs, 
      including akathisia (32.6%), headache (16.7%), constipation (10.7%), and nausea 
      (10.4%). Mean body weight increased <1kg; 9.3% had >/=7% weight gain; 5.7% had 
      sedation; 3% had somnolence. Mean changes in laboratory values, vital signs, 
      ECGs, and ophthalmology parameters were not clinically significant. Mean YMRS 
      total score decreased by -15.2 at week 16. LIMITATIONS: Uncontrolled, open-label 
      design. CONCLUSIONS: Open-label cariprazine 3-12 (mean 6.2) mg/d for up to 16 
      weeks was generally well tolerated, with low (<10%) rates of sedation and >/=7% 
      weight gain. Although akathisia occurred in 33%, it yielded discontinuation in 
      <5%.
CI  - Copyright (c) 2017 The Authors. Published by Elsevier B.V. All rights reserved.
FAU - Ketter, Terence A
AU  - Ketter TA
AD  - Stanford University School of Medicine, Stanford, CA, USA. Electronic address: 
      tketter@stanford.edu.
FAU - Sachs, Gary S
AU  - Sachs GS
AD  - Massachusetts General Hospital, Boston, MA, USA.
FAU - Durgam, Suresh
AU  - Durgam S
AD  - Allergan Inc., Jersey City, NJ, USA.
FAU - Lu, Kaifeng
AU  - Lu K
AD  - Allergan Inc., Jersey City, NJ, USA.
FAU - Starace, Anju
AU  - Starace A
AD  - Allergan Inc., 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.
LA  - eng
SI  - ClinicalTrials.gov/NCT01059539
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170818
PL  - Netherlands
TA  - J Affect Disord
JT  - Journal of affective disorders
JID - 7906073
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - F6RJL8B278 (cariprazine)
SB  - IM
MH  - Adult
MH  - Antipsychotic Agents/adverse effects/*therapeutic use
MH  - Bipolar Disorder/*drug therapy
MH  - Depression
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Weight Gain
OTO - NOTNLM
OT  - Atypical antipsychotic
OT  - Bipolar disorder
OT  - Cariprazine
OT  - Longer-term safety
OT  - Mania
OT  - Tolerability
EDAT- 2017/08/28 06:00
MHDA- 2018/04/14 06:00
CRDT- 2017/08/28 06:00
PHST- 2017/02/17 00:00 [received]
PHST- 2017/06/22 00:00 [revised]
PHST- 2017/08/14 00:00 [accepted]
PHST- 2017/08/28 06:00 [pubmed]
PHST- 2018/04/14 06:00 [medline]
PHST- 2017/08/28 06:00 [entrez]
AID - S0165-0327(17)30241-0 [pii]
AID - 10.1016/j.jad.2017.08.040 [doi]
PST - ppublish
SO  - J Affect Disord. 2018 Jan 1;225:350-356. doi: 10.1016/j.jad.2017.08.040. Epub 
      2017 Aug 18.