Double-blind, placebo-controlled pilot study of adjunctive quetiapine SR in the treatment of PMS/PMDD

Hum Psychopharmacol. 2015 Nov;30(6):425-34. doi: 10.1002/hup.2494. Epub 2015 Jul 19.

Abstract

Objective: Premenstrual dysphoric disorder (PMDD), a more severe form of premenstrual syndrome (PMS), afflicts 5-8% of reproductive age women and results in significant functional impairment. We conducted a double-blind, placebo-controlled trial of adjunctive quetiapine in patients with PMS/PMDD who had inadequate response to selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor therapy for their symptoms.

Methods: A PMS/PMDD diagnosis was confirmed by 2-month prospective diagnostic assessment of PMS/PMDD using the Prospective Record of the Impact and Severity of Premenstrual Symptoms (PRISM) calendar. Women were randomized equally to receive quetiapine sustained-release (SR) or placebo (25-mg starting dose) during the luteal phase for 3 months. Outcome variables included the Hamilton Depression and Anxiety Scales, Clinical Global Impression Scale, and PRISM.

Results: Twenty women were enrolled in the treatment phase. Although the study was underpowered, greater reductions in luteal phase mood ratings were observed in the quetiapine group on the 17-item Hamilton Depression Rating Scale, Clinical Global Impression improvement rating, and PRISM daily score. The quetiapine group showed most improvement in symptoms of mood lability, anxiety, and irritability.

Conclusion: This small double-blind study suggests that adjunctive treatment with quetiapine SR may be a useful addition to selective serotonin reuptake inhibitor therapy in women with PMS/PMDD by reducing symptoms and improving quality of life.

Keywords: SNRIs; SSRIs; antidepressant medications; premenstrual dysphoric disorder; premenstrual syndrome; quetiapine.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Antipsychotic Agents / administration & dosage
  • Antipsychotic Agents / therapeutic use*
  • Delayed-Action Preparations
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Pilot Projects
  • Premenstrual Dysphoric Disorder / drug therapy*
  • Premenstrual Dysphoric Disorder / physiopathology
  • Premenstrual Syndrome / drug therapy*
  • Premenstrual Syndrome / physiopathology
  • Prospective Studies
  • Psychiatric Status Rating Scales
  • Quality of Life
  • Quetiapine Fumarate / administration & dosage
  • Quetiapine Fumarate / therapeutic use*
  • Selective Serotonin Reuptake Inhibitors / administration & dosage
  • Selective Serotonin Reuptake Inhibitors / therapeutic use
  • Severity of Illness Index
  • Treatment Outcome

Substances

  • Antipsychotic Agents
  • Delayed-Action Preparations
  • Serotonin Uptake Inhibitors
  • Quetiapine Fumarate