A Randomized, Double-Blind Study of Increasing or Maintaining Duloxetine Dose in Patients Without Remission of Major Depressive Disorder After Initial Duloxetine Therapy
J Clin Psychiatry 2008;69(9):1383-1392
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Objective: To compare efficacy of remaining on duloxetine 60
mg to increasing to 120 mg q.d. in patients without remission of major
depressive disorder (MDD) after 6 weeks at 60 mg.
Method: This double-blind, parallel study was conducted in
adults with MDD (DSM-IV-TR criteria). Patients initially randomly assigned to
duloxetine 60 mg for 6 weeks with a 17-item Hamilton Rating Scale for
Depression (HAM-D-17) score > 7 (nonremitters) were randomly reassigned to 60
mg or 120 mg duloxetine for 8 weeks. Patients with a HAM-D-17 score <= 7
(remitters) continued on duloxetine 60 mg. The primary objective was to compare
time to remission (HAM-D-17 score <= 7) between rerandomized groups. Secondary
objectives included evaluation of HAM-D-17 and Inventory of Depressive
Symptomatology assessments and safety and tolerability evaluations in
nonremitters and remitters. Patients were enrolled from November 2004 to
Results: Nonremitters randomly reassigned to 60 mg and 120 mg
achieved similar time to remission and similar improvements on efficacy
measures. Remission was achieved in 30.0% and 30.5% in the 60-mg and 120-mg
groups, respectively. Of the remitters, 85.5% continued to be in remission at
study end. Other than a greater incidence of hyperhidrosis and chest pain in
the 120-mg group, adverse events were similar between groups, as were
discontinuations due to adverse events.
Conclusion: Nonremitters to 60 mg of duloxetine for 6 weeks
randomly reassigned to 60 mg or 120 mg of duloxetine demonstrated continued
symptom improvement in the 8-week extension. Patients randomly reassigned to
120 mg showed no advantage over those who continued on 60 mg. Duloxetine was
well tolerated at both doses and had similar safety profiles.
Trial Registration: clinicaltrials.gov Identifier: NCT00191061