Posted by bleauberry on September 4, 2008, at 18:03:40
I put the results of this interesting study first so you don't have to read the whole thing if you don't want to. My only reservation is that the study was funded by the company that makes Milnacipran. Regardless, even if the numbers were considerably lower than they appear, but they may be accurate I don't know, potential results look better than average as psych treatments go.
Results
Improvement in MADRS total score was greater in the pindolol group than in the placebo group from day 7 (p=0.03). Responder rates in the clinical global impression were 97.2% for the pindolol group and 60.6% for the placebo group. The treatment was well tolerated with the most common side effects being nausea (28.2%; 35.9%), vomiting (7.7%; 23.1%), hot flushes (15.4%; 5.1%) and sweating (12.8%; 12.8%).
Research Article
Milnacipran and pindolol: a randomized trial of reduction of antidepressant latency
Michael T. Isaac 1 2 *, Maria B. Isaac 3 4, Fidel Gallo 1, Alan Tournoux 5
1South London and Maudsley NHS Trust, Psychopharmacology Evaluation Unit, Ladywell Building, University Hospital Lewisham, London SE13 6LH, UK
2Section of Clinical Neuropharmacology, Institute of Psychiatry, London, UK
3South London and Maudsley NHS Trust, Gresham Psychiatric Intensive Care Unit, Bethlem Royal Hospital, Monks Orchard Road, Beckenham, Kent BR3 3BX, UK
4Section of Brain Maturation, Institute of Psychiatry, London, UK
5Pierre Fabre Research, Division of Pierre Fabre Médicaments, SA, France
email: Michael T. Isaac (misaac@stekel.demon.co.uk)*Correspondence to Michael T. Isaac, South London and Maudsley NHS Trust, Psychopharmacology Evaluation Unit, Ladywell Building, University Hospital Lewisham, London SE13 6LH, UK.
Funded by:
Pierre Fabre Research, Division of Pierre Fabre Médicaments SAKeywords
SSRI milnacipran pindolol 5-HT1A receptor depression antidepressants randomized controlled trial
AbstractBackground
New, better tolerated and faster treatments for depression are needed. Patients are understandably unhappy with having to wait 3 to 4 weeks for a response to an antidepressant, while experiencing side effects almost immediately. This frequently has an adverse effect on compliance and engagement with treatment.Aims
The primary objective was to assess the activity of pindolol on the onset of antidepressive response of milnacipran. The secondary objective was to assess the number of responders among the patients who received milnacipran and pindolol versus patients who received milnacipran and placebo. The tertiary objective was to evaluate the safety of milnacipran and pindolol versus milnacipran and placebo.Method
Randomized, double-blind, placebo-controlled study over 42 days.Setting
Inner city London community mental health teams.Participants
80 patients were selected and gave written consent to treatment, 78 were randomized (39 in each group) and evaluated for safety (intention-to-treat, ITT, safety data set), 77 (ITT efficacy data set), and 64 (per protocol, PP, data set) were evaluated for efficacy. The mean age was 31.9 for the pindolol group and 32.3 for the placebo.Intervention
All patients received milnacipran 50 mg twice a day plus either pindolol 2.5 mg (the pindolol group) or matching placebo (the placebo group) three times a day.Outcome measures
The main efficacy variable was the Montgomery-Ĺsberg depression rating scale (MADRS) score at days 0, 4, 7, 10, 14, 21, 28, 42 on PP data set in an observation carried (OC) approach. Secondary efficacy variables were clinical global impression (global improvement) and Hamilton depression rating scale (HDRS).Results
Improvement in MADRS total score was greater in the pindolol group than in the placebo group from day 7 (p=0.03). Responder rates in the clinical global impression were 97.2% for the pindolol group and 60.6% for the placebo group. The treatment was well tolerated with the most common side effects being nausea (28.2%; 35.9%), vomiting (7.7%; 23.1%), hot flushes (15.4%; 5.1%) and sweating (12.8%; 12.8%).Conclusion
The milnacipran and pindolol combination is safe, well tolerated and efficacious in major depression, and represents a rational strategy for the possible acceleration or potentiation of antidepressant action. Copyright © 2003 John Wiley & Sons, Ltd.--------------------------------------------------------------------------------
Received: 11 April 2003; Accepted: 30 June 2003
Digital Object Identifier (DOI)
poster:bleauberry
thread:850376
URL: http://www.dr-bob.org/babble/20080903/msgs/850376.html