PMID- 17669574
OWN - NLM
STAT- MEDLINE
DCOM- 20071206
LR  - 20121115
IS  - 0278-5846 (Print)
IS  - 0278-5846 (Linking)
VI  - 31
IP  - 7
DP  - 2007 Oct 1
TI  - Effectiveness, safety, and tolerability of ziprasidone for treating schizophrenia 
      patients undergoing usual care: a 12-month, open-label, flexible-dose, 
      naturalistic observational trial.
PG  - 1401-9
AB  - OBJECTIVE: This is a first report from a long-term study aimed to evaluate 
      efficacy, safety, tolerability, cognitive functioning, and quality of life 
      outcomes during ziprasidone treatment of chronic schizophrenia patients in the 
      "real-world". METHOD: Seventy clinically unstable schizophrenia patients with 
      persistent symptoms or troublesome side effects were assigned to a 12-month, 
      open-label, flexible-dose (40-160 mg/day), large-scale, naturalistic trial. 
      Outcome measures were taken at baseline, 6, and 12 months, and included the 
      Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impression 
      (CGI-S) scale, the Global Assessment of Functioning Scale (GAF) scores, 
      treatment-emergent adverse events, body weight, and drug attitude. RESULTS: 
      Thirty-two patients fully completed the study protocol. A discontinuation of 
      treatment for any cause occurred in 54.3% of patients; the mean time until 
      discontinuation was 4.4 +/- 2.7 months. A discontinuation due to lack of clinical 
      efficacy was more predominantly linked to patient perception (25.7%) than to 
      physicians' conclusions alone (8.6%), adverse events (11.4%), and other reasons 
      (8.6%). After controlling daily dose of ziprasidone, concomitant medications and 
      sex, ANCOVA revealed improvement in PANSS factors, and global functioning among 
      patients who had completed the study. Improvement in PANSS and GAF dimensions was 
      evident at a 6-month visit, and it continued until the endpoint. When a cutoff of 
      20% improvement of PANSS total scores was used, the response rate among 
      completers was 43.8%. Most common side effects were: fatigue, sleep disturbances, 
      and headache. Ziprasidone did not appear to be linked to weight gain. CONCLUSION: 
      This study suggests that ziprasidone may be beneficial for long-term treatment of 
      schizophrenia patients in terms of severity of symptoms, and general functioning. 
      Ziprasidone is well tolerated during the long-term treatment of chronic 
      schizophrenia patients undergoing usual care.
FAU - Ratner, Yael
AU  - Ratner Y
AD  - Acute Department, Sha'ar Menashe Mental Health Center, Mobile Post Hefer 38814, 
      Hadera, Israel.
FAU - Gibel, Anatoly
AU  - Gibel A
FAU - Yorkov, Vladimir
AU  - Yorkov V
FAU - Ritsner, Michael S
AU  - Ritsner MS
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20070621
PL  - England
TA  - Prog Neuropsychopharmacol Biol Psychiatry
JT  - Progress in neuro-psychopharmacology & biological psychiatry
JID - 8211617
RN  - 0 (Antipsychotic Agents)
RN  - 0 (Piperazines)
RN  - 0 (Thiazoles)
RN  - 6UKA5VEJ6X (ziprasidone)
SB  - IM
MH  - Adult
MH  - Antipsychotic Agents/administration & dosage/adverse effects/*therapeutic use
MH  - Body Weight/drug effects
MH  - Chronic Disease
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Piperazines/administration & dosage/adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Schizophrenia/*drug therapy
MH  - Thiazoles/administration & dosage/adverse effects/*therapeutic use
EDAT- 2007/08/03 09:00
MHDA- 2007/12/07 09:00
CRDT- 2007/08/03 09:00
PHST- 2007/02/08 00:00 [received]
PHST- 2007/06/01 00:00 [revised]
PHST- 2007/06/13 00:00 [accepted]
PHST- 2007/08/03 09:00 [pubmed]
PHST- 2007/12/07 09:00 [medline]
PHST- 2007/08/03 09:00 [entrez]
AID - S0278-5846(07)00199-6 [pii]
AID - 10.1016/j.pnpbp.2007.06.008 [doi]
PST - ppublish
SO  - Prog Neuropsychopharmacol Biol Psychiatry. 2007 Oct 1;31(7):1401-9. doi: 
      10.1016/j.pnpbp.2007.06.008. Epub 2007 Jun 21.