Flushes and Sertraline Trial

The primary aim of FAST is to determine if 6 weeks of treatment with sertraline (50 mg daily for 2 weeks, followed by 100 mg per day for 4 weeks, if tolerated) results in greater reduction in hot flush score (frequency x severity), frequency and severity compared to placebo among women with moderate to severe hot flushes.

The Secondary Aims:To determine the effect of treatment with sertraline on quality of life, sleep, sexual function, mood, and cognitive function. To determine if a modified, short version of a sexual function instrument is valid.

Inclusion criteria

• Age 40 - 60 years old
• Report > 14 hot flushes per week
• Willing to be randomized to sertraline or placebo
• Sign informed consent

Exclusion criteria

• History of bilateral oophorectomy
• Breast or ovarian cancer
• Liver disease
• Kidney disease requiring dialysis
• History of major depression (reported history of depression requiring therapy, hospitalization for depression, taking antidepressant drugs, history of suicide attempt)
• History of bipolar affective disorder (reported history of bipolar disorder requiring therapy, medications, hospitalized for bipolar disorder)
• Seizure disorder
• History of hypersensitivity to sertraline or to SSRIs
• Pregnancy or breast feeding
• Any medical or psychiatric condition which, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial;
• No estrogens or progestins for 3 months prior to screening or during enrollment
• Selective estrogen receptor modulators (SERMS)
• The following medications: clonidine, gabapentin, tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, selective serotonin reuptake inhibitors (SSRIs), megesterol , oral contraceptives, androgens; and medications that are listed on the Pfizer Pharmaceutical drug insert as "contraindicated"