PMID- 11910258
OWN - NLM
STAT- MEDLINE
DCOM- 20020513
LR  - 20190910
IS  - 0271-0749 (Print)
IS  - 0271-0749 (Linking)
VI  - 22
IP  - 2
DP  - 2002 Apr
TI  - Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive 
      disorder including effects of baseline insomnia.
PG  - 137-47
AB  - This study assessed whether fluoxetine, sertraline, and paroxetine differ in 
      efficacy and tolerability in depressed patients and the impact of baseline 
      insomnia on outcomes. Patients (N = 284) with DSM-IV major depressive disorder 
      were randomly assigned in a double-blind fashion to fluoxetine, paroxetine, or 
      sertraline for 10 to 16 weeks of treatment. Using the Hamilton Rating Scale for 
      Depression (HAM-D) sleep disturbance factor score, patients were categorized into 
      low (<4) or high (>or=4) baseline insomnia subgroups. Changes in depression and 
      insomnia were assessed. Safety assessments included treatment-emergent adverse 
      events (AEs), reasons for discontinuation, and AEs leading to discontinuation. In 
      addition, AEs were evaluated within insomnia subgroups to determine emergence of 
      activation or sedation. Depression improvement, assessed with the HAM-D-17 total 
      score, was similar among treatments in all patients (p = 0.365) and the high (p = 
      0.853) and low insomnia (p = 0.415) subgroups. Insomnia improvement, assessed 
      with the HAM-D sleep disturbance factor score, was similar among treatments in 
      all patients (p = 0.868) and in the high (p = 0.852) and low insomnia (p = 0.982) 
      subgroups. Analyses revealed no significant differences between treatments in the 
      percentages of patients with substantial worsening, any worsening, worsening at 
      endpoint, or improvement at endpoint in the HAM-D sleep disturbance factor in 
      either insomnia subgroup. Treatments were well tolerated in most patients. No 
      significant differences between treatments in the incidence of AEs suggestive of 
      activation or sedation were seen in the insomnia subgroups. These data show no 
      significant differences in acute treatment efficacy and tolerability across 
      fluoxetine, sertraline, and paroxetine in major depressive disorder patients. 
      Improvement in overall depression and in associated insomnia was achieved by most 
      patients regardless of baseline insomnia.
FAU - Fava, Maurizio
AU  - Fava M
AD  - Depression Clinical and Research Program, Massachusetts General Hospital, Boston, 
      Massachusetts 02114, USA. mfava@partners.org
FAU - Hoog, Sharon L
AU  - Hoog SL
FAU - Judge, Rajinder A
AU  - Judge RA
FAU - Kopp, Joan B
AU  - Kopp JB
FAU - Nilsson, Mary E
AU  - Nilsson ME
FAU - Gonzales, Jill S
AU  - Gonzales JS
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antidepressive Agents)
RN  - 01K63SUP8D (Fluoxetine)
RN  - 41VRH5220H (Paroxetine)
RN  - QUC7NX6WMB (Sertraline)
SB  - IM
MH  - Acute Disease
MH  - Adverse Drug Reaction Reporting Systems
MH  - Antidepressive Agents/adverse effects/*therapeutic use
MH  - Depressive Disorder, Major/diagnosis/*drug therapy/psychology
MH  - Double-Blind Method
MH  - Fluoxetine/adverse effects/*therapeutic use
MH  - Humans
MH  - Paroxetine/adverse effects/*therapeutic use
MH  - Personality Inventory
MH  - Sertraline/adverse effects/*therapeutic use
MH  - Sleep Initiation and Maintenance Disorders/diagnosis/*drug therapy/psychology
MH  - Treatment Outcome
EDAT- 2002/03/23 10:00
MHDA- 2002/05/15 10:01
CRDT- 2002/03/23 10:00
PHST- 2002/03/23 10:00 [pubmed]
PHST- 2002/05/15 10:01 [medline]
PHST- 2002/03/23 10:00 [entrez]
AID - 10.1097/00004714-200204000-00006 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2002 Apr;22(2):137-47. doi: 
      10.1097/00004714-200204000-00006.