Symptoms and functioning with aripiprazole once-monthly injection as maintenance treatment for bipolar I disorder
| Autor: | Robert D. McQuade, N. Jin, Kevin Cox, Pamela Perry, Margaretta Nyilas, Pedro Such, Raymond Sanchez, B. Johnson, William H. Carson, Joseph R. Calabrese, Joan Amatniek, Peter Hertel |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Bipolar I disorder Bipolar Disorder medicine.medical_treatment Aripiprazole Young Mania Rating Scale Placebo Drug Administration Schedule Injections 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Surveys and Questionnaires mental disorders otorhinolaryngologic diseases medicine Humans Bipolar disorder Psychiatry Antipsychotic Middle Aged medicine.disease 030227 psychiatry Psychiatry and Mental health Clinical Psychology Mood Delayed-Action Preparations Quality of Life Female medicine.symptom Psychology Mania 030217 neurology & neurosurgery medicine.drug Antipsychotic Agents |
| Zdroj: | Journal of affective disorders. 227 |
| ISSN: | 1573-2517 |
| Popis: | Background Effects of maintenance treatment with aripiprazole once-monthly 400 mg (AOM 400) on symptoms and functioning were assessed in adults with bipolar I disorder (BP-I) after a manic episode. Methods Patients were stabilized on oral aripiprazole, cross-titrated to AOM 400, then randomized in a 52-week, double-blind, placebo-controlled, withdrawal phase. Prespecified secondary outcomes are reported: time to hospitalization for mood episode, Young Mania Rating Scale (YMRS), Montgomery-Asberg Depression Rating Scale (MADRS), Clinical Global Impression–Bipolar scale, Functioning Assessment Short Test (FAST), and Brief Quality of Life in Bipolar Disorder questionnaire. Time to hospitalization for mood episode was analyzed using log-rank test and changes from baseline using mixed model for repeated measures or analysis of covariance. Results AOM 400 significantly increased time to hospitalization for any mood episode versus placebo (P=0.0002). YMRS total scores decreased with oral aripiprazole; improvements were maintained with AOM 400. After randomization, YMRS scores changed little with AOM 400 but worsened with placebo (P=0.0016), and MADRS scores, already low at trial initiation, did not differ between groups. FAST score improvements were maintained with AOM 400 but not placebo (P=0.0287). Limitations Results are generalizable to patients with BP-I stabilized on aripiprazole following a manic episode. Conclusions Patients with BP-I experiencing an acute manic episode exhibited symptomatic and functional improvements during stabilization with oral aripiprazole and AOM 400 that were maintained with continued AOM 400 treatment but not placebo. AOM 400 is the first once-monthly long-acting injectable antipsychotic to demonstrate efficacy in maintenance treatment of the manic phase of BP-I. |
| Databáze: | OpenAIRE |
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