Suzuki, N., Ninomiya, M., Maruta, T., Hosonuma, S., Yoshioka, N., Ohara, T., . . . Ishizuka, B. (2011). Clinical study on the efficacy of fluvoxamine for psychological distress in gynecologic cancer patients. International Journal of Gynecological Cancer, 21, 1143–1149.

To investigate the safety and efficacy of fluvoxamine to treat anxiety and depression in patients with gynecologic cancer

For eight weeks patients were treated with escalating doses:

• Week 1: 25 mg once daily
• Week 2: 50 mg once daily
• Week 3: 50 mg twice daily
• Week 4: 50 mg three times daily
• Week 5 and onward: Dosing varied according to each patient's condition. 

Subjects were evaluated at two, four, six, and eight weeks.

• The study reported on a sample of 10 female patients.
• Median patient age was 53 years, with a range of 33–66 years.
• All patients had gynecologic cancers and were diagnosed at least two weeks prior to study entry.
• All patients had a HADS score of at least 11, indicating clinically relevant conditions. Mean HADS score was 19.
• Five patients had a diagnosed adjustment disorder, and five patients had major depression.

• Single site
• Setting not specified
• Japan

Patients were undergoing active antitumor treatment.

Prospective trial design 

• Hospital Anxiety and Depression Score (HADS)
• Short Form 36 Health Survey (SF-36)

Compared to HADS anxiety and depression scores at baseline, the scores were significantly lower after four weeks of treatment (p < 0.05) and remained significantly lower. After eight weeks, researchers noted significant improvements in SF-36 scores for vitality, mental health, and emotional role functioning (p < 0.05). No adverse effects of treatment were reported.

Fluvoxamine treatment of patients with gynecologic cancer who had clinically relevant anxiety and depression appears to reduce anxiety and depression. The small study sample precludes firm conclusions.

• The sample size was small, with fewer than 30 participants.
• The study had risks of bias because it had no control group, no blinding, and no random assignment.
• All patients had, at baseline, significant depression and anxiety, so findings cannot be generalized to patients with levels of these symptoms that are not clinically relevant. The follow-up period was only eight weeks; longer-term safety and efficacy are unknown.

Fluvoxamine as provided appeared to be effective in management of clinically relevant anxiety and depression in women with gynecologic cancer. Studies of anxiety and depression are often done with patients who do not have clinically significant problems in these areas at baseline, often making findings nonsignificant. This study provided some support for effective use of medication in patients with clinically relevant levels of anxiety and depression. The sample was very small, and the study design had multiple risks of bias. To determine which groups of patients can benefit from treatment, larger, well-designed trials are warranted.