دورية أكاديمية
Ziprasidone with adjunctive mood stabilizer in the maintenance treatment of bipolar I disorder: long-term changes in weight and metabolic profiles.
العنوان: | Ziprasidone with adjunctive mood stabilizer in the maintenance treatment of bipolar I disorder: long-term changes in weight and metabolic profiles. |
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المؤلفون: | Kemp DE; Case Western Reserve University, University Hospitals Case Medical Center, Cleveland, OH, USA. kemp.david@gmail.com, Karayal ON, Calabrese JR, Sachs GS, Pappadopulos E, Ice KS, Siu CO, Vieta E |
المصدر: | European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology [Eur Neuropsychopharmacol] 2012 Feb; Vol. 22 (2), pp. 123-31. Date of Electronic Publication: 2011 Jul 28. |
نوع المنشور: | Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 9111390 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-7862 (Electronic) Linking ISSN: 0924977X NLM ISO Abbreviation: Eur Neuropsychopharmacol Subsets: MEDLINE |
أسماء مطبوعة: | Original Publication: Amsterdam : Elsevier, c1990- |
مواضيع طبية MeSH: | Adjuvants, Immunologic/*therapeutic use , Antipsychotic Agents/*therapeutic use , Bipolar Disorder/*drug therapy , Body Weight/*drug effects , Metabolic Diseases/*drug therapy , Piperazines/*therapeutic use , Thiazoles/*therapeutic use, Bipolar Disorder/complications ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Humans ; Lithium Chloride/therapeutic use ; Longitudinal Studies ; Male ; Metabolic Diseases/etiology ; Metabolome/drug effects ; Psychiatric Status Rating Scales ; Valproic Acid/therapeutic use |
مستخلص: | This analysis was conducted to compare the effects of adjunctive ziprasidone or placebo on metabolic parameters among patients receiving maintenance treatment with lithium or valproate. We also tested whether metabolic syndrome (MetS) and other risk factors were associated with baseline characteristics and treatment response. In the stabilization phase (Phase 1), 584 bipolar I disorder (DSM-IV) patients received 2.5-4 months of open label ziprasidone (80-160 mg/d) plus lithium or valproic acid (ZIP+MS). Patients who achieved at least 8 weeks of clinical stability were subsequently randomized into Phase 2 to 6-months of double-blind treatment with ZIP+MS (n=127) vs. placebo+MS (n=113). At baseline of Phase 1, MetS was found in 111 participants (23%). Participants with MetS (vs. non-MetS participants) were more likely to be aged 40 years or older, had significantly more severe manic symptoms, higher abdominal obesity, and higher BMI. Increase in abdominal obesity was associated with lower manic symptom improvement (p<0.05, as assessed by MRS change score) during Phase 1, while symptom improvement differed across racial groups. In the Phase 2 double-blind phase, the ZIP+MS group had similar weight and metabolic profiles compared to the placebo+MS group across visits. These results corroborate existing findings on ziprasidone which exhibits a neutral weight and metabolic profile in the treatment of schizophrenia and bipolar patients. Our findings suggest that MetS is highly prevalent in patients with bipolar disorder, may be associated with greater manic symptom severity, and may predict treatment outcomes. (Copyright © 2011 Elsevier B.V. All rights reserved.) |
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معلومات مُعتمدة: | KL2 RR024990 United States RR NCRR NIH HHS; KL2 RR024990-02 United States RR NCRR NIH HHS |
المشرفين على المادة: | 0 (Adjuvants, Immunologic) 0 (Antipsychotic Agents) 0 (Piperazines) 0 (Thiazoles) 614OI1Z5WI (Valproic Acid) 6UKA5VEJ6X (ziprasidone) G4962QA067 (Lithium Chloride) |
تواريخ الأحداث: | Date Created: 20110730 Date Completed: 20120423 Latest Revision: 20240604 |
رمز التحديث: | 20240604 |
مُعرف محوري في PubMed: | PMC3225596 |
DOI: | 10.1016/j.euroneuro.2011.06.005 |
PMID: | 21798721 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1873-7862 |
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DOI: | 10.1016/j.euroneuro.2011.06.005 |