Mirtazapine, yohimbine or olanzapine augmentation therapy for serotonin reuptake-associated female sexual dysfunction: a randomized, placebo controlled trial.
BACKGROUND
Many agents have been proposed as potential treatments for SSRI-associated sexual dysfunction, but few placebo-controlled trials have been reported.


METHODS
After a 1-month baseline evaluation, pre-menopausal women with moderate to severe sexual dysfunction associated with the institution of fluoxetine therapy were randomized to augmentation therapy with placebo (N=39), mirtazapine (N=36), yohimbine (N=35) or olanzapine (N=38) for a 6-week period. Outcomes were measured using a daily diary, a biweekly self-report assessment, and a computer assisted structured interview.


RESULTS
At baseline, orgasm was most severely impaired. After 6 weeks, there was statistically significant improvement on most measures for the overall group of patients, however there were few differences between treatment groups. Isolated treatment differences were observed for the patient self-report of overall sexual function (olanzapine superior to placebo) and the structured interview sexual satisfaction item (mirtazapine inferior to placebo).


CONCLUSIONS
No drug assessed was consistently associated with differences from placebo. The results of the study do not support uncontrolled reports of efficacy for these agents in premenopausal women.
Michelson
David
D
Lilly Research Laboratories, Lilly Corporate Center 6026, Indianapolis, IN 46285, USA. dmichelson@lilly.com
Kociban
Kristen
K
Tamura
Roy
R
Morrison
Mary F
MF
D000317:Adrenergic alpha-Antagonists / Q000494:pharmacology* / Q000627:therapeutic use; D000328:Adult; D000929:Antidepressive Agents, Tricyclic / Q000494:pharmacology* / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000494:pharmacology* / Q000627:therapeutic use; D001569:Benzodiazepines; D005260:Female; D005473:Fluoxetine / Q000009:adverse effects* / Q000627:therapeutic use; D006801:Humans; D008803:Mianserin / Q000031:analogs & derivatives* / Q000494:pharmacology* / Q000627:therapeutic use; D000078785:Mirtazapine; D000077152:Olanzapine; D017060:Patient Satisfaction; D010890:Pirenzepine / Q000031:analogs & derivatives* / Q000494:pharmacology* / Q000627:therapeutic use; D010919:Placebos; D017697:Premenopause; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D012735:Sexual Dysfunction, Physiological / Q000139:chemically induced* / Q000188:drug therapy*; D016896:Treatment Outcome; D015016:Yohimbine / Q000494:pharmacology* / Q000627:therapeutic use
D000317:Adrenergic alpha-Antagonists; D000929:Antidepressive Agents, Tricyclic; D014150:Antipsychotic Agents; D001569:Benzodiazepines; D005473:Fluoxetine; D008803:Mianserin; D000078785:Mirtazapine; D000077152:Olanzapine; D010890:Pirenzepine; D010919:Placebos; D017367:Selective Serotonin Reuptake Inhibitors; D015016:Yohimbine