A 12-Month Open-Label Extension Study of the Safety and Tolerability of Lisdexamfetamine Dimesylate for Major Depressive Disorder in Adults
| Autor: | Joan Gu, Manisha Madhoo, Matthew Dauphin, Olga Brawman-Mintzer, Roger S. McIntyre, Rajnish Mago, Dan V. Iosifescu, Brooke Geibel, Elias Sarkis, Cynthia Richards, Richard H. Weisler |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Original Contributions Venlafaxine Lisdexamfetamine Dimesylate lisdexamfetamine dimesylate safety and tolerability 03 medical and health sciences chemistry.chemical_compound Young Adult 0302 clinical medicine Internal medicine medicine Duloxetine Escitalopram Humans Pharmacology (medical) augmentation therapy Aged Sertraline Depressive Disorder Major major depressive disorder business.industry Middle Aged medicine.disease Antidepressive Agents 030227 psychiatry Psychiatry and Mental health Blood pressure Tolerability chemistry ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Major depressive disorder Central Nervous System Stimulants Drug Therapy Combination Female business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Journal of Clinical Psychopharmacology |
| ISSN: | 1533-712X 0271-0749 |
| Popis: | Supplemental digital content is available in the text. Purpose/Background Psychostimulant augmentation is considered a potential treatment strategy for individuals with major depressive disorder who do not adequately respond to antidepressant monotherapy. The primary objective of this 12-month open-label extension study was to evaluate the safety and tolerability of lisdexamfetamine dimesylate (LDX) as augmentation therapy to an antidepressant in adults with major depressive disorder. Methods/Procedures Eligible adults who completed 1 of 3 short-term antecedent LDX augmentation of antidepressant monotherapy studies were treated with dose-optimized LDX (20–70 mg) for up to 52 weeks while continuing on the index antidepressant (escitalopram, sertraline, venlafaxine extended-release, or duloxetine) assigned during the antecedent short-term studies. Safety and tolerability assessments included the occurrence of treatment-emergent adverse events and vital sign changes. Findings/Results All 3 antecedent studies failed to meet the prespecified primary efficacy endpoint, so this open-label study was terminated early. Headache (15.5% [241/1559]), dry mouth (13.6% [212/1559]), insomnia (13.1% [204/1559]), and decreased appetite (12.1% [189/1559]) were the most frequently reported treatment-emergent adverse events. The greatest mean ± SD increases observed for systolic and diastolic blood pressure and for pulse were 2.6 ± 10.85 and 1.7 ± 7.94 mm Hg and 6.9 ± 10.27 bpm, respectively. Monitoring determined that less than 1% of participants experienced potentially clinically important changes in systolic blood pressure (10 [0.6%]), diastolic blood pressure (8 [0.5%]), or pulse (6 [0.4%]). Implications/Conclusions The overall safety and tolerability of long-term LDX augmentation of antidepressant monotherapy was consistent with the profiles of the short-term antecedent studies, with no evidence of new safety signals. |
| Databáze: | OpenAIRE |
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