TY - JOUR
T1 - A post hoc analysis of negative symptoms and psychosocial function in patients with schizophrenia
T2 - A 40-week randomized, double-blind study of ziprasidone versus haloperidol followed by a 3-year double-blind extension trial
AU - Stahl, Stephen M.
AU - Malla, Ashok
AU - Newcomer, John W.
AU - Potkin, Steven G.
AU - Weiden, Peter J.
AU - Harvey, Philip D.
AU - Loebel, Antony
AU - Watsky, Eric
AU - Siu, Cynthia O.
AU - Romano, Steve
PY - 2010/8/1
Y1 - 2010/8/1
N2 - Schizophrenia is a persistent, lifelong illness such that enduring functional improvements may only occur for years. This post hoc analysis in stable outpatients with schizophrenia investigated the negative symptom efficacy and treatment outcomes of ziprasidone (80-160 mg/d given twice a day, mean modal dose of 112 mg/d; and 80-120 mg/d given every day, mean modal dose of 96 mg/d) versus haloperidol (5-20 mg/d, mean modal dose of 12 mg/d) in a randomized, 40-week, double-blind study, followed by a double-blind continuation trial that extended up to 156 additional weeks. Symptomatic and functional recovery criteria were met when subjects attained both negative symptom remission and adequate psychosocial functioning based on the 4 Quality-of-Life subscales (instrumental role, interpersonal relations, participation in community, and intrapsychic foundations). Negative symptom remission (P = 0.005), as well as sustained adequate functioning (6 months) in instrumental role (P = 0.04) and participation in community (P = 0.02), was associated with significantly shorter time to remission in the ziprasidone 80 to 160 mg group than in the haloperidol group, as was the combination of symptomatic and functional recovery during the 196-week double-blind study period. A similar pattern was observed for the ziprasidone 80 to 120 mg group, which showed significant differences versus haloperidol in negative symptom remission and instrumental role functioning (but not other Quality-of-Life subscale measures). The clinically relevant outcome differences detected in this post hoc exploratory analysis support the potential for both enhanced remission in negative symptoms and psychosocial recovery during long-term treatment with an atypical agent and add to our understanding regarding the degree to which negative symptom remission can be attained in the maintenance phase.
AB - Schizophrenia is a persistent, lifelong illness such that enduring functional improvements may only occur for years. This post hoc analysis in stable outpatients with schizophrenia investigated the negative symptom efficacy and treatment outcomes of ziprasidone (80-160 mg/d given twice a day, mean modal dose of 112 mg/d; and 80-120 mg/d given every day, mean modal dose of 96 mg/d) versus haloperidol (5-20 mg/d, mean modal dose of 12 mg/d) in a randomized, 40-week, double-blind study, followed by a double-blind continuation trial that extended up to 156 additional weeks. Symptomatic and functional recovery criteria were met when subjects attained both negative symptom remission and adequate psychosocial functioning based on the 4 Quality-of-Life subscales (instrumental role, interpersonal relations, participation in community, and intrapsychic foundations). Negative symptom remission (P = 0.005), as well as sustained adequate functioning (6 months) in instrumental role (P = 0.04) and participation in community (P = 0.02), was associated with significantly shorter time to remission in the ziprasidone 80 to 160 mg group than in the haloperidol group, as was the combination of symptomatic and functional recovery during the 196-week double-blind study period. A similar pattern was observed for the ziprasidone 80 to 120 mg group, which showed significant differences versus haloperidol in negative symptom remission and instrumental role functioning (but not other Quality-of-Life subscale measures). The clinically relevant outcome differences detected in this post hoc exploratory analysis support the potential for both enhanced remission in negative symptoms and psychosocial recovery during long-term treatment with an atypical agent and add to our understanding regarding the degree to which negative symptom remission can be attained in the maintenance phase.
KW - functional recovery
KW - haloperidol
KW - long-term negative symptom efficacy
KW - remission
KW - ziprasidone
UR - http://www.scopus.com/inward/record.url?scp=77955176471&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=77955176471&partnerID=8YFLogxK
U2 - 10.1097/JCP.0b013e3181e69042
DO - 10.1097/JCP.0b013e3181e69042
M3 - Article
C2 - 20571437
AN - SCOPUS:77955176471
VL - 30
SP - 425
EP - 430
JO - Journal of Clinical Psychopharmacology
JF - Journal of Clinical Psychopharmacology
SN - 0271-0749
IS - 4
ER -