PMID- 27025469
OWN - NLM
STAT- MEDLINE
DCOM- 20170102
LR  - 20191210
IS  - 1876-2026 (Electronic)
IS  - 1876-2018 (Linking)
VI  - 20
DP  - 2016 Apr
TI  - Safety and effectiveness of divalproex sodium extended release containing regimen 
      in Indian patients with bipolar I disorder in continuation phase: Results of 
      EASED registry.
PG  - 32-8
LID - S1876-2018(15)00281-6 [pii]
LID - 10.1016/j.ajp.2015.11.009 [doi]
AB  - The study was conducted to evaluate the safety and effectiveness of divalproex 
      sodium XR containing regimen in patients with bipolar disorder (BPD) who are in 
      continuation phase. It was an open-label, prospective, observational study 
      conducted from July 2010 to December 2011 at 48 sites across India. Adult 
      patients with bipolar I disorder of manic or mixed type fulfilling the DSM-IV 
      criteria and who were in the continuation phase were included. Safety (primary 
      outcome) was assessed by incidence of treatment emergent adverse events (AEs). 
      Effectiveness (secondary outcome), was evaluated by proportion of patients who 
      did not have a relapse, change in Clinical Global Impression Score-BP 
      version-Severity of Illness (CGI-BP) and Young's Mania Rating Scale (YMRS) score. 
      Data was recorded at three visits: visit-1 (baseline), visit-2 (end of 2 months +/- 
      7 days) and visit-3 (end of 4 months +/- 14 days), and summarised using descriptive 
      statistics. p<0.05 was considered statistically significant. A total of 489 and 
      468 patients were included in the safety and effectiveness analyses, 
      respectively. Of the 66 AEs reported, 57 (89.0%) were mild and 7 (10.9%) were 
      moderate (data missing for 2 events). In total, 75.0% (48/64) of the AEs were 
      related to the study drug. No serious AEs reported (N=64). No relapse observed in 
      93.3% of patients. There was a significant (p<0.0001) reduction in the YMRS and 
      CGI-BP scores from baseline to visit-3. Our study confirms the results of earlier 
      studies in terms of good tolerability and effectiveness of divalproex sodium XR 
      containing regimen in this study population.
CI  - Copyright (c) 2015 Elsevier B.V. All rights reserved.
FAU - Shah, Nilesh
AU  - Shah N
AD  - L. T. M. Medical College and General Hospital, Mumbai, India. Electronic address: 
      drnilshah@hotmail.com.
FAU - Reddy, M S
AU  - Reddy MS
AD  - Asha Bipolar Clinic, Asha Hospital, Hyderabad, India.
FAU - Vohra, Sandeep
AU  - Vohra S
AD  - Indraprastha Apollo Hospitals, New Delhi, India.
FAU - Chaudhuri, Uday
AU  - Chaudhuri U
AD  - Gaurinath Shastri Memorial Clinic, Kolkata, India.
FAU - Mohanasundaram, Senthilnathan
AU  - Mohanasundaram S
AD  - Sanofi, Mumbai, India.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20151213
PL  - Netherlands
TA  - Asian J Psychiatr
JT  - Asian journal of psychiatry
JID - 101517820
RN  - 0 (Antimanic Agents)
RN  - 0 (Delayed-Action Preparations)
RN  - 614OI1Z5WI (Valproic Acid)
SB  - IM
MH  - Adult
MH  - Antimanic Agents/administration & dosage/adverse effects/*pharmacology
MH  - Bipolar Disorder/*drug therapy
MH  - Delayed-Action Preparations
MH  - Female
MH  - Humans
MH  - India
MH  - Male
MH  - Middle Aged
MH  - *Outcome Assessment, Health Care
MH  - Prospective Studies
MH  - *Registries
MH  - Valproic Acid/administration & dosage/adverse effects/*pharmacology
OTO - NOTNLM
OT  - Bipolar disorder
OT  - Depression
OT  - Mania
OT  - Safety
OT  - Valproic acid
EDAT- 2016/03/31 06:00
MHDA- 2017/01/04 06:00
CRDT- 2016/03/31 06:00
PHST- 2015/04/13 00:00 [received]
PHST- 2015/11/25 00:00 [revised]
PHST- 2015/11/29 00:00 [accepted]
PHST- 2016/03/31 06:00 [entrez]
PHST- 2016/03/31 06:00 [pubmed]
PHST- 2017/01/04 06:00 [medline]
AID - S1876-2018(15)00281-6 [pii]
AID - 10.1016/j.ajp.2015.11.009 [doi]
PST - ppublish
SO  - Asian J Psychiatr. 2016 Apr;20:32-8. doi: 10.1016/j.ajp.2015.11.009. Epub 2015 
      Dec 13.