PMID- 16012271 OWN - NLM STAT- MEDLINE DCOM- 20051206 LR - 20190911 IS - 0271-0749 (Print) IS - 0271-0749 (Linking) VI - 25 IP - 4 DP - 2005 Aug TI - Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. PG - 301-10 AB - BACKGROUND: In an earlier 21-day, placebo-controlled trial, ziprasidone was efficacious in improving symptoms of mania and was well tolerated. To confirm these results, a similarly designed 21-day trial was conducted. METHODS: Inpatients with bipolar I disorder, manic or mixed, were randomized to ziprasidone (40 to 80 mg BID) or placebo. Efficacy rating scales were derived from the Schedule for Affective Disorders and Schizophrenia-Change Bipolar Scale (SADS-CB). SADS-CB-derived Mania Rating Scale (MRS) total score was the primary efficacy parameter. Secondary SADS-CB-derived efficacy parameters included Manic Syndrome and Behavior and Ideation Subscales, Hamilton Depression Rating Scale (HAM-D), and the Montgomery Asberg Depression Rating Scale (MADRS). The Clinical Global Impression-Severity Scale (CGI-S), the Global Assessment of Functioning (GAF), and the Positive and Negative Syndrome Scale (PANSS) were also assessed. RESULTS: Sixty-five placebo and 137 ziprasidone patients were evaluable for efficacy. Baseline-to-endpoint mean changes in MRS scores were -11.1 for ziprasidone and -5.6 for placebo (all patients, last observation carried forward [LOCF]; P < 0.01). Ziprasidone produced significantly greater improvements in Manic Syndrome (P < or = 0.01) and Behavior and Ideation Subscales (P < or = 0.001), CGI-S score, (P < or = 0.001), PANSS Total (P < or = 0.01) and Positive Subscale (P < or = 0.001) scores, and GAF (P < or = 0.001). With ziprasidone, significant improvements were observed from Day 2 onward for MRS and CGI-S at all time points except Day 4 for MRS. Treatment-related discontinuations due to adverse events were 5.8% for ziprasidone and 1.5% for placebo (P = 0.20). CONCLUSIONS: Ziprasidone was well tolerated, rapidly efficacious, and superior to placebo in improving symptoms and global illness severity in these inpatients with acute bipolar mania, both manic and mixed episodes. FAU - Potkin, Steven G AU - Potkin SG AD - Neuropsychiatric Center, University of California-Irvine, 101 City Drive South, Bldg. 3, Orange, CA 92868-3298, USA. sgpotkin@uci.edu FAU - Keck, Paul E Jr AU - Keck PE Jr FAU - Segal, Scott AU - Segal S FAU - Ice, Kathleen AU - Ice K FAU - English, Patricia AU - English P LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Clin Psychopharmacol JT - Journal of clinical psychopharmacology JID - 8109496 RN - 0 (Antipsychotic Agents) RN - 0 (Piperazines) RN - 0 (Thiazoles) RN - 6UKA5VEJ6X (ziprasidone) SB - IM MH - Acute Disease MH - Adult MH - Aged MH - Antipsychotic Agents/administration & dosage/*therapeutic use MH - Bipolar Disorder/*drug therapy MH - Dose-Response Relationship, Drug MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Hospitalization MH - Humans MH - Male MH - Middle Aged MH - Piperazines/administration & dosage/*therapeutic use MH - Psychiatric Status Rating Scales MH - Thiazoles/administration & dosage/*therapeutic use MH - Treatment Outcome EDAT- 2005/07/14 09:00 MHDA- 2005/12/13 09:00 CRDT- 2005/07/14 09:00 PHST- 2005/07/14 09:00 [pubmed] PHST- 2005/12/13 09:00 [medline] PHST- 2005/07/14 09:00 [entrez] AID - 00004714-200508000-00003 [pii] AID - 10.1097/01.jcp.0000169068.34322.70 [doi] PST - ppublish SO - J Clin Psychopharmacol. 2005 Aug;25(4):301-10. doi: 10.1097/01.jcp.0000169068.34322.70.