PMID- 7954486
OWN - NLM
STAT- MEDLINE
DCOM- 19941221
LR  - 20190914
IS  - 0362-5664 (Print)
IS  - 0362-5664 (Linking)
VI  - 17 Suppl 1
DP  - 1994
TI  - Safety and efficacy during long-term treatment with moclobemide.
PG  - S74-87
AB  - Safety aspects [adverse events, blood pressure and heart rate, weight, and 
      laboratory tests (liver parameters, hemoglobin, leukocytes)] of long-term 
      treatment in 1,120 patients are discussed. Adverse events during this long-term 
      treatment were also compared with those of a subgroup of these patients who, 
      before long-term treatment, were treated on a short-term basis (n = 706). 
      Efficacy [Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression of 
      Efficacy (CGI), and occurrence of relapses and recurrences] in a homogeneous 
      sample of 485 patients is also discussed. The adverse events most frequently 
      observed during long-term treatment were insomnia, headache, and dizziness. 
      Insomnia and headache were also most often occurring in the compared sample of 
      patients with short-term treatment, whereas dizziness during this treatment 
      period ranked at the fifth position. Supine and standing mean blood pressure did 
      not consistently change during long-term treatment, the most prominent increases 
      in comparison with baseline were seen in the period > 1 year of treatment (6.3 mm 
      Hg supine/7.2 mm Hg standing). Comparison of blood pressure values in the 
      hypertensive range at baseline and during long-term treatment revealed no 
      statistical difference (McNemar test p = 0.07829). Mean heart rate slightly 
      decreased during long-term treatment (by a maximum of 6.3 beats/min supine, 8.2 
      beats/min standing). Mean weight did not change between baseline and treatment 
      end point. There were 23 patients with a weight loss of 10 kg or more and 16 
      patients with a weight gain of 10 kg or more. For none of the laboratory 
      parameters tested was there a statistical significance regarding shifts from 
      normal to pathological values. HAM-D mean total scores in the above-mentioned 
      subgroup of patients decreased from 25.05 points at baseline (n = 485) to 7.88 
      points after 1 year of treatment (n = 139). Seventy-five patients who had 
      favorably responded to treatment (total responders n = 300) relapsed during the 
      first 6 months of treatment. During the second half-year of treatment the 
      recurrence rate was 14.8%, and during the third 6 months the recurrence rate was 
      12.2%. CGI in the same subsample of patients in whom HAMD was evaluated (n = 485) 
      compared with those patients who did not drop out during the short-term period up 
      to 44 days and entered long-term treatment (n = 401) showed that the percentage 
      of the ratings "no change/worse" was higher in the sample that also included 
      patients who withdrew from treatment during the short-term period.(ABSTRACT 
      TRUNCATED AT 400 WORDS)
FAU - Moll, E
AU  - Moll E
AD  - Department of Clinical Research, F. Hoffmann-La Roche Ltd., Basel, Switzerland.
FAU - Neumann, N
AU  - Neumann N
FAU - Schmid-Burgk, W
AU  - Schmid-Burgk W
FAU - Stabl, M
AU  - Stabl M
FAU - Amrein, R
AU  - Amrein R
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PL  - United States
TA  - Clin Neuropharmacol
JT  - Clinical neuropharmacology
JID - 7607910
RN  - 0 (Antidepressive Agents)
RN  - 0 (Benzamides)
RN  - PJ0Y7AZB63 (Moclobemide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antidepressive Agents/adverse effects/*therapeutic use
MH  - Benzamides/adverse effects/*therapeutic use
MH  - Blood Pressure/drug effects
MH  - Body Weight/drug effects
MH  - Depressive Disorder/*drug therapy/microbiology
MH  - Double-Blind Method
MH  - Female
MH  - Heart Rate/drug effects
MH  - Humans
MH  - Liver Function Tests
MH  - Male
MH  - Middle Aged
MH  - Moclobemide
MH  - Psychiatric Status Rating Scales
MH  - Recurrence
EDAT- 1994/01/01 00:00
MHDA- 1994/01/01 00:01
CRDT- 1994/01/01 00:00
PHST- 1994/01/01 00:00 [pubmed]
PHST- 1994/01/01 00:01 [medline]
PHST- 1994/01/01 00:00 [entrez]
AID - 10.1097/00002826-199417001-00009 [doi]
PST - ppublish
SO  - Clin Neuropharmacol. 1994;17 Suppl 1:S74-87. doi: 
      10.1097/00002826-199417001-00009.