Luteal phase sertraline treatment for premenstrual dysphoric disorder. Results of a double-blind, placebo-controlled, crossover study.
OBJECTIVE
To test the efficacy of late-luteal phase dosing of sertraline hydrochloride in women with moderate-to-severe premenstrual dysphoric disorder. This highly prevalent disorder often causes significant psychosocial impairment.


METHODS
Double-blind, crossover trial of each 2-menstrual cycle of baseline, sertraline treatment, and placebo. Randomization to sertraline treatment vs placebo occurred after a 2-cycle, drug-free period.


METHODS
A large outpatient multispecialty clinic in central Texas.


METHODS
Fifty-seven women aged 19 to 49 years with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, diagnosis of premenstrual dysphoric disorder.


METHODS
Late-luteal phase treatment with sertraline hydrochloride in daily doses of 50 mg (cycle 1) followed by 100 mg (cycle 2) vs placebo.


METHODS
The 22-item calendar of premenstrual experiences was completed daily and constituted the primary outcome measure, consisting of a total score and behavioral and physical factor scores.


RESULTS
A repeated-measures analysis of variance for crossover designs found a significant beneficial effect from sertraline treatment in improving the calendar of premenstrual experiences total (P < .01), behavioral factor (P < .01), and physical factor (P < .04) scores. Most women improved when taking sertraline, 50 mg, although a dose increase to 100 mg yielded further improvement in approximately 25% of women. Use of sertraline was extremely well tolerated; the only adverse event reported by 10% or more of women was insomnia in 8 (14%) of them.


CONCLUSIONS
Luteal phase treatment with sertraline was a safe and effective treatment for moderate-to-severe premenstrual dysphoric disorder. Further controlled studies are needed to confirm the results of this preliminary study.
Department of Pharmacy, Scott & White Memorial Hospital, Temple, Tex., USA. djermain@swmail.sw.org
D M
DM
Jermain
C K
CK
Preece
R L
RL
Sykes
T J
TJ
Kuehl
P J
PJ
Sulak
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008183:Luteal Phase; D008875:Middle Aged; D011293:Premenstrual Syndrome / Q000188:drug therapy* / Q000523:psychology*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D020280:Sertraline / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D000928:Antidepressive Agents; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline