title: Clinical study on the efficacy of fluvoxamine for psychological distress in gynecologic cancer patients.
abstract: BACKGROUND
  Diagnosis of cancer causes psychological distress. The present study investigated the safety and efficacy of fluvoxamine therapy in gynecologic cancer patients with either adjustment disorder or major depression after cancer was diagnosed.
  
  
  METHODS
  Screening with the Hospital Anxiety and Depression Scale (HADS) was conducted at least 2 weeks after notification of the diagnosis of cancer in 214 gynecologic cancer patients hospitalized between January 2007 and December 2008. The HADS cutoff score was set at 11 points or greater. Informed consent to the study was obtained from 10 patients, and fluvoxamine was administered for 8 weeks. As primary end points, the safety and efficacy of fluvoxamine were evaluated using the HADS and the SF-36. As a secondary end point, the Clinical Global Impression was determined.
  
  
  RESULTS
  The total HADS score, the anxiety score, and the depression score were significantly reduced after 6, 4, and 6 weeks of treatment, respectively. The SF-36 revealed significant improvement in vitality, mental health, and role (emotional) after 8 weeks of treatment. In the 5 patients with adjustment disorder, only the HADS anxiety score was significantly reduced after 4 weeks. In the 5 patients with major depression, the total HADS score, the anxiety score, and the depression score were significantly reduced after 6, 8, and 6 weeks, respectively. According to the SF-36, the adjustment-disorder groups showed significant improvement in mental health after 8 weeks of treatment, whereas the major-depression group showed significant improvement in vitality and role (emotional) after 8 weeks. No adverse events occurred in any subject. Assessment of the Clinical Global Impression suggested that fluvoxamine improved psychological distress in all 10 subjects.
  
  
  CONCLUSIONS
  The present findings suggest that fluvoxamine is useful for alleviating psychological distress, including adjustment disorder and major depression, in gynecologic cancer patients. Management of psychological distress after diagnosis of cancer is important.
authors.affiliation: Department of Obstetrics and Gynecology, St Marianna University School of Medicine, Kanagawa, Japan. nao@mariannna-u.ac.jp
authors.forename: Nao
authors.initials: N
authors.lastname: Suzuki
authors.forename: Masato
authors.initials: M
authors.lastname: Ninomiya
authors.forename: Tomoko
authors.initials: T
authors.lastname: Maruta
authors.forename: Shinji
authors.initials: S
authors.lastname: Hosonuma
authors.forename: Norihito
authors.initials: N
authors.lastname: Yoshioka
authors.forename: Tatsuru
authors.initials: T
authors.lastname: Ohara
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Nishigaya
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Kobayashi
authors.forename: Kazushige
authors.initials: K
authors.lastname: Kiguchi
authors.forename: Bunpei
authors.initials: B
authors.lastname: Ishizuka
mesh_terms: D000328:Adult; D000368:Aged; D014151:Anti-Anxiety Agents / Q000008:administration & dosage*; D001008:Anxiety Disorders / Q000188:drug therapy*; D003131:Combined Modality Therapy; D005260:Female; D016666:Fluvoxamine / Q000008:administration & dosage*; D005833:Genital Neoplasms, Female / Q000188:drug therapy / Q000523:psychology* / Q000601:surgery; D006801:Humans; D008875:Middle Aged; D011594:Psychometrics; D011788:Quality of Life; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D014151:Anti-Anxiety Agents; D016666:Fluvoxamine