Duloxetine in the Long-Term Treatment of Major Depressive Disorder
Notice bibliographique
Résumé
BACKGROUND: Depression is a chronic recurring disorder and guidelines recommend long-term therapy. This clinical trial evaluated the long-term (1 year) safety and efficacy of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, in patients with DSM-IV major depressive disorder. METHOD: This was an open-label, 52-week, multinational clinical trial in outpatients (age > or = 18 years) who received duloxetine at 80 mg/day (administered 40 mg twice daily) to 120 mg/day (administered 60 mg twice daily) for up to 1 year. RESULTS: A total of 1279 patients had postbaseline data. Of these, 520 were exposed to duloxetine for at least 360 days, yielding approximately 808 patient-years of total exposure. Mean changes in Clinical Global Impressions-Severity of Illness scale (CGI-S) score, 17-item Hamilton Rating Scale for Depression total score and subfactor scores, Beck Depression Inventory-II score, and Sheehan Disability Scale score and mean Patient Global Impression-Improvement scale (PGI-I) scores all showed highly significant (p <.001) improvements at all assessment times. The estimated probabilities of improvement in CGI-S and PGI-I scores at week 1 were 40.4% and 59.2%, respectively, and at week 2 were 70.0% and 78.3%. The estimated probabilities of remission at weeks 6, 28, and 52 were 50.8%, 75.6%, and 81.8%, respectively. Adverse events led to discontinuation in 218 patients (17.0%). The most frequent specific events leading to discontinuation were nausea (1.5%), somnolence (1.4%), vomiting (0.9%), hypomania (0.8%), pregnancy (0.8%), dizziness (0.6%), insomnia (0.6%), and hypertension (0.5%). Treatment-emergent adverse events that were reported by > 10% of patients included nausea, insomnia, headache, somnolence, dry mouth, dizziness, constipation, sweating increase, anxiety, diarrhea, and fatigue. Most events occurred early in the study. Of those events that first occurred or worsened after discontinuation, only dizziness (8.3%) occurred in more than 5% of patients. Mean changes from baseline to last observation for standing and supine pulse were less than 2 b.p.m. Mean changes in blood pressure (< 1.0 mm Hg), corrected QT interval (< 1 msec), and body weight (2.4 kg [5.3 lb]) were not clinically significant. Laboratory analyses varied across visits, and mean changes after 52 weeks were generally close to zero. The incidence of laboratory values above or below normal limits at any time during treatment was low. CONCLUSION: Duloxetine was effective, safe, and well tolerated in the long-term treatment of major depression at a dose of 80 to 120 mg/day in this study.
Récupéré en direct depuis OpenAlex et désinversé. Les résumés ne sont pas conservés dans cette base de données : les index inversés représentent 8,6 Go des 9,3 Go de texte de la base, et le serveur dispose de 13 Go libres.
Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,002 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».