Duloxetine for the treatment of mood disorder in cancer patients: a 12-week case-control clinical trial

Hum Psychopharmacol. 2011 Jun-Jul;26(4-5):291-9. doi: 10.1002/hup.1202. Epub 2011 Jul 12.

Abstract

Objective: The aim of this study was to investigate the efficacy and tolerability of duloxetine in cancer patients with mood disorder (MD) by means of a comparison with a matched control group of patients with MD without medical illness.

Methods: Fifty-nine consecutive patients with MD were enrolled in this prospective case-control study and received duloxetine 60/120 mg per day for 12 weeks. Twenty-seven patients were affected by cancer, whereas 32 had an MD without cancer. All the patients were assessed by means of efficacy and effectiveness tolerability scales for depression (Montgomery-Asberg Depression Rating Scale and Hospital Anxiety and Depression Scale), anxiety (State-Trait Anxiety Inventory-Y1/Y2) and severity of symptoms (Clinical Global Impression (CGI)-Severity) at baseline (T0), after 4 weeks (T1) and 12 weeks (T2). The CGI-Improvement, CGI-Effectiveness Index and Dosage Record Treatment Emergent Symptom Scale were administered at T1 and T2.

Results: A significant global improvement in all the efficacy measures was found. The results showed no significant interaction 'Time X Group', suggesting a similar improvement in efficacy scores for cancer-depressed patients and depressed patients without cancer. No difference was found between the two groups with regard to drop-out percentage, effectiveness and tolerability.

Conclusion: Although the results of this case-control study are preliminary, they suggest that duloxetine can be considered a good option for the treatment of MD in cancer patients.

Publication types

  • Controlled Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Anti-Anxiety Agents / adverse effects
  • Anti-Anxiety Agents / therapeutic use*
  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / therapeutic use*
  • Anxiety / etiology
  • Anxiety / prevention & control
  • Case-Control Studies
  • Depression / etiology
  • Depression / prevention & control
  • Diagnostic and Statistical Manual of Mental Disorders
  • Duloxetine Hydrochloride
  • Female
  • Humans
  • Italy
  • Male
  • Middle Aged
  • Mood Disorders / complications
  • Mood Disorders / drug therapy*
  • Mood Disorders / physiopathology
  • Neoplasms / complications*
  • Neoplasms / psychology
  • Patient Dropouts
  • Psychiatric Status Rating Scales
  • Quality of Life
  • Severity of Illness Index
  • Thiophenes / adverse effects
  • Thiophenes / therapeutic use*

Substances

  • Anti-Anxiety Agents
  • Antidepressive Agents
  • Thiophenes
  • Duloxetine Hydrochloride