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September 24, 1997, Vol 278, No. 12 >
ARTICLE | September 24, 1997

Symptomatic Improvement of Premenstrual Dysphoric Disorder With Sertraline Treatment: Title and subTitle BreakA Randomized Controlled Trial FREE

Kimberly A. Yonkers, MD; Uriel Halbreich, MD; Ellen Freeman, PhD; Candace Brown, PharmD; Jean Endicott, PhD; Ellen Frank, PhD; Barbara Parry, MD; Teri Pearlstein, MD; Sally Severino, MD; Anna Stout, PhD; Andrea Stone, MD; Wilma Harrison, MD
[+] Author Affiliations

Additional members of the Sertraline Premenstrual Dysphoric Collaborative Study Group appear at the end of this article.

Reprints: Kimberly A. Yonkers, MD, The University of Texas Southwestern Medical Center, St Paul Professional Bldg I, Suite 520, 5959 Harry Hines Blvd, Dallas, TX 75235.


JAMA. 1997;278(12):983-988. doi:10.1001/jama.1997.03550120043031
Text Size: A A A
Published online
Article
References

Context.  —Premenstrual dysphoric disorder is an important cause of symptoms and functional impairment in menstruating women.

Objective.  —To evaluate the efficacy of sertraline hydrochloride for treatment of premenstrual dysphoria by measuring changes in symptom expression and functional impairment.

Design.  —Two screening cycles followed by 1 single-blind placebo cycle and 3 cycles of randomized, double-blind, placebo treatment.

Setting.  —Twelve university-affiliated outpatient psychiatry and gynecology clinics.

Patients.  —Of the 447 women who requested participation, 243 met criteria for premenstrual dysphoric disorder and were randomized; 200 women completed the study.

Intervention.  —A flexible (50-150 mg) daily dose of sertraline hydrochloride.

Main Outcome Measures.  —The Daily Record of Severity of Problems, Hamilton Rating Scale for Depression, Clinical Global Impression Scale, and Social Adjustment Scale.

Results.  —Mean (±SD) total daily symptom scores decreased significantly (P<.001) in the sertraline-treated (64±22 to 44±19) compared with the placebotreated (62±22 to 54±24) groups. Significant improvement (P<.05) was found for all clinically derived symptom clusters (depressive, physical, and anger/irritability symptoms). Hamilton Rating Scale for Depression scores decreased by 44% and 29% in the sertraline and placebo groups, respectively (P<.002). End-point global ratings showed much or very much improvement in 62% of the active treatment group and 34% of the placebo treatment group (P<.001). Reported functional impairment was substantial at baseline. Improvement in psychosocial functioning with treatment was similar to what is found in studies of major depression.

Conclusions.  —Sertraline was significantly better than placebo for treatment of premenstrual dysphoria as reflected by symptomatic improvement and change in reported functional impairment. Serotonin reuptake inhibitors such as sertraline are useful therapeutic options for women with premenstrual dysphoria.

REFERENCES

1 +
Woods NF, Most A, Dery GK.  Prevalence of perimenstrual symptoms . Am J Public Health . 1982;;72:1257-1264.
2 +
Merikangas KR, Foeldenyl M, Angst J.  The Zurich Study, XIX: patterns of menstrual disturbances in the community: results of the Zurich Cohort Study . Eur Arch Psychiatry Clin Neurosci . 1993;;243:23-32.
3 +
Hurt SW, Schnurr PP, Severino SK, et al.  Late luteal phase dysphoric disorder in 670 women evaluated for premenstrual complaints . Am J Psychiatry . 1992;;149:525-530.
4 +
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition . Washington, DC: American Psychiatric Association; 1994;.
5 +
Bancroft J.  The premenstrual syndrome: a reappraisal of the concept and the evidence . Psychol Med Monogr Suppl . 1993;;24:1-46.
6 +
Yonkers KA.  Treatment of premenstrual dysphoric disorder . Curr Rev Mood Anxiety Disord . 1997;;1:215-237.
7 +
Freeman E, Sondheimer S, Rickels K, Polansky M.  Ineffectiveness of progesterone suppository treatment for premenstrual syndrome . JAMA . 1990;;264:349-353.
8 +
Freeman EW, Rickels K, Sondheimer SJ, Polansky M.  A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome . JAMA . 1995;;274:51-57.
9 +
Graham CA, Sherwin BB.  A prospective treatment study of premenstrual symptoms using a triphasic oral contraceptive . J Psychosom Res . 1992;;36:257-266.
10 +
Burnet RB, Radden HS, Easterbrook EG, McKinnon RA.  Premenstrual syndrome and spironolactone . Aust N Z J Obstet Gynaecol . 1991;;31:366-368.
11 +
Vellacott ID, Shroff NE, Pearce MY, Stratford ME, Akbar FA.  A double-blind, placebo-controlled evaluation of spironolactone in the premenstrual syndrome . Curr Med Res Opin . 1987;;10:450-456.
12 +
Kendall KE, Schnurr PP.  The effects of vitamin B6 supplementation on premenstrual symptoms . Obstet Gynecol . 1987;;70:145-149.
13 +
Christensen AP, Oei TPS.  Correlates of premenstrual dysphoria in help-seeking women . J Affect Disord . 1995;;33:47-55.
14 +
Khoo SK, Munro C, Battistutta D.  Evening primrose oil and treatment of premenstrual syndrome . Med J Aust . 1990;;153:189-192.
15 +
London RS, Bradley L, Chiamori NY.  Effect of a nutritional supplement on premenstrual symptomatology in women with premenstrual syndrome: a double-blind longitudinal study . J Am Coll Nutr . 1991;;10:494-499.
16 +
Berger CP, Presser B.  Alprazolam in the treatment of two subsamples of patients with late luteal phase dysphoric disorder: a double-blind, placebocontrolled crossover study . Obstet Gynecol . 1994;;84:379-385.
17 +
Harrison WM, Endicott J, Nee J.  Treatment of premenstrual dysphoria with alprazolam . Arch Gen Psychiatry . 1990;;47:270-275.
18 +
Smith S, Rinehart JS, Ruddock VE, Schiff I.  Treatment of premenstrual syndrome with alprazolam: results of a double-blind, placebo-controlled, randomized crossover clinical trial . Obstet Gynecol . 1987;;70:37-43.
19 +
Schmidt PJ, Grover GN, Rubinow DR.  Alprezolam in the treatment of premenstrual syndrome: a double-blind, placebo-controlled trial . Arch Gen Psychiatry . 1993;;50:467-473.
20 +
Menkes DB, Taghavi E, Mason PA, Spears GFS, Howard RC.  Fluoxetine treatment of severe premenstrual syndrome . BMJ . 1992;;305:346-347.
21 +
Steiner M, Steinberg S, Stewart D, et al.  Fluoxetine in the treatment of premenstrual dysphoria . N Engl J Med . 1995;;332:1529-1534.
22 +
Stone AB, Pearlstein TB, Brown WA.  Fluoxetine in the treatment of late luteal phase dysphoric disorder . J Clin Psychiatry . 1991;;52:290-293.
23 +
Wood SH, Mortola JF, Chan Yuen-F, Moossazadeh F, Yen SSC.  Treatment of premenstrual syndrome with fluoxetine: a double-blind, placebo-controlled, crossover study . Obstet Gynecol . 1992;;80:339-344.
24 +
Sundblad C, Modigh K, Andersch B, Eriksson E.  Clomipramine effectively reduces premenstrual irritability and dysphoria: a placebo-controlled trial . Acta Psychiatr Scand . 1992;;85:39-47.
25 +
Sundblad C, Hedberg MA, Eriksson E.  Clomipramine administered during the luteal phase reduces the symptoms of premenstrual syndrome: a placebo-controlled trial . Neuropsychopharmacology . 1993;;9:133-145.
26 +
Eriksson E, Hedberg MA, Andersch B, Sundblad C.  The serotonin reuptake inhibitor paroxetine is superior to the noradrenaline reuptake inhibitor maprotiline in the treatment of premenstrual syndrome . Neuropsychopharmacology .1995;;12:169-176.
27 +
Su T-P, Schmidt PJ, Danaceau MA, et al.  Fluoxetine in the treatment of premenstrual dysphoria . Neuropsychopharmacology . 1997;;16:346-356.
28 +
Endicott J, Harrison W. Daily Rating of Severity of Problems Form . New York, NY: Dept of Research Assessment and Training, New York State Psychiatric Institute; 1990;.
29 +
Endicott J, Nee J, Cohne J, Halbreich U.  Premenstrual changes: patterns and correlates of daily ratings . J Affect Disord . 1986;;10:127-135.
30 +
Williams JBW, Gibbon M, First MB, et al.  The Structured Clinical Interview for DSM-III-R (SCID), II: multisite test-retest reliability . Arch Gen Psychiatry . 1992;;49:630-636.
31 +
Hamilton M.  A rating scale for depression . J Neurol Neurosurg . 1960;;23:56-62.
32 +
Guy W. ECDEU Assessment Manual for Psychopharmacology . Revised 1st ed. Rockville, Md: US Dept of Health, Education and Welfare; 1976;.
33 +
Weissman MM, Bothwell S.  Assessment of social adjustment by patient self-report . Arch Gen Psychiatry . 1976;;33:1111-1115.
34 +
Statistical Analysis Software. Cary, NC: SAS Institute Inc; 1996.
35 +
Weissman MM, Prusoff BA, Thompson WD, Harding PS, Myers JK. Social adjustment by selfreport in a community sample and in psychiatric outpatients . J Nerv Ment Dis . 1978;;166:317-362.
36 +
Brzezinski AA, Wurtman JJ, Wurtman RJ, Gleason R, Greenfield J, Nader T.  D-Fenfluramine suppresses the increased calorie and carbohydrate intakes and improves the mood of women with premenstrual depression . Obstet Gynecol . 1990;;76:296-300.
37 +
Reimherr FW, Chouinard G, Cohn CK, et al.  Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled multicenter comparison study in outpatients with major depression . J Clin Psychiatry . 1990;;51( (12, suppl B) ):18-27.
38 +
Doogan DP, Caillard V.  Sertraline in the prevention of depression . Br J Psychiatry . 1992;;160:217-222.
39 +
Thase ME, Fava M, Halbreich U, et al.  A placebo-controlled randomized clinical trial comparing sertraline and imipramine for the treatment of dysthymia . Arch Gen Psychiatry . 1996;;53:777-784.
40 +
Pearlstein TB, Stone AB, Lund SA, Scheft H, Zlotnick C, Brown WA. A double-blind comparison of fluoxetine, buproprion and placebo in premenstrual dysphoric disorder. Presented at the annual meeting of the American Psychiatric Association, May 23, 1995, Miami, Fla. Abstract NR314.
41 +
Halbreich U, Tworek H.  Altered serotonergic activity in women with dysphoric premenstrual syndromes . Int J Psychiatry Med . 1993;;23:1-27.
42 +
Rapkin AJ.  The role of serotonin in premenstrual syndrome . Clin Obstet . 1992;;35:629-636.
43 +
Biegnon A, Reches A, Snyder L, McEwen BS.  Serotonergic and noradrenergic receptors in the rat brain: modulation of chronic exposure to ovarian hormones . Life Sci . 1983;;32:2015-2021.
44 +
Sumner BEH, Fink G.  Estrogen increases the density of 5-hydroxytryptamine-2A receptors in cerebral cortex and nucleus accumbens in the female rat . J Steroid Biochem Mol Biol . 1995;;54:15-20.
45 +
Harrison WM, Endicott J, Nee J, Glick H, Rabkin JG.  Characteristics of women seeking treatment for premenstrual syndrome . Psychosomatics . 1989;;30:405-411.
46 +
Stout AL, Steege JF, Blazer DG, George LK.  Comparison of lifetime diagnosis in premenstrual syndrome clinic and community samples . J Nerv Ment Dis . 1986;;174:517-521.
47 +
Pearlstein TB, Frank E, Rivera-Tovar A, Thoft JS, Jacobs E, Mieczkowski TA.  Prevalence of axis I and axis II disorders in women with late luteal phase dysphoric disorder . J Affect Disord . 1990;;20:129-134.
48 +
Yonkers KA, Gullion C, Williams A, Novak K, Rush AJ.  Paroxetine as a treatment for premenstrual dysphoric disorder . J Clin Psychopharmacol . 1996;;16:3-8.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Woods NF, Most A, Dery GK.  Prevalence of perimenstrual symptoms . Am J Public Health . 1982;;72:1257-1264.
2 +
Merikangas KR, Foeldenyl M, Angst J.  The Zurich Study, XIX: patterns of menstrual disturbances in the community: results of the Zurich Cohort Study . Eur Arch Psychiatry Clin Neurosci . 1993;;243:23-32.
3 +
Hurt SW, Schnurr PP, Severino SK, et al.  Late luteal phase dysphoric disorder in 670 women evaluated for premenstrual complaints . Am J Psychiatry . 1992;;149:525-530.
4 +
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition . Washington, DC: American Psychiatric Association; 1994;.
5 +
Bancroft J.  The premenstrual syndrome: a reappraisal of the concept and the evidence . Psychol Med Monogr Suppl . 1993;;24:1-46.
6 +
Yonkers KA.  Treatment of premenstrual dysphoric disorder . Curr Rev Mood Anxiety Disord . 1997;;1:215-237.
7 +
Freeman E, Sondheimer S, Rickels K, Polansky M.  Ineffectiveness of progesterone suppository treatment for premenstrual syndrome . JAMA . 1990;;264:349-353.
8 +
Freeman EW, Rickels K, Sondheimer SJ, Polansky M.  A double-blind trial of oral progesterone, alprazolam, and placebo in treatment of severe premenstrual syndrome . JAMA . 1995;;274:51-57.
9 +
Graham CA, Sherwin BB.  A prospective treatment study of premenstrual symptoms using a triphasic oral contraceptive . J Psychosom Res . 1992;;36:257-266.
10 +
Burnet RB, Radden HS, Easterbrook EG, McKinnon RA.  Premenstrual syndrome and spironolactone . Aust N Z J Obstet Gynaecol . 1991;;31:366-368.
11 +
Vellacott ID, Shroff NE, Pearce MY, Stratford ME, Akbar FA.  A double-blind, placebo-controlled evaluation of spironolactone in the premenstrual syndrome . Curr Med Res Opin . 1987;;10:450-456.
12 +
Kendall KE, Schnurr PP.  The effects of vitamin B6 supplementation on premenstrual symptoms . Obstet Gynecol . 1987;;70:145-149.
13 +
Christensen AP, Oei TPS.  Correlates of premenstrual dysphoria in help-seeking women . J Affect Disord . 1995;;33:47-55.
14 +
Khoo SK, Munro C, Battistutta D.  Evening primrose oil and treatment of premenstrual syndrome . Med J Aust . 1990;;153:189-192.
15 +
London RS, Bradley L, Chiamori NY.  Effect of a nutritional supplement on premenstrual symptomatology in women with premenstrual syndrome: a double-blind longitudinal study . J Am Coll Nutr . 1991;;10:494-499.
16 +
Berger CP, Presser B.  Alprazolam in the treatment of two subsamples of patients with late luteal phase dysphoric disorder: a double-blind, placebocontrolled crossover study . Obstet Gynecol . 1994;;84:379-385.
17 +
Harrison WM, Endicott J, Nee J.  Treatment of premenstrual dysphoria with alprazolam . Arch Gen Psychiatry . 1990;;47:270-275.
18 +
Smith S, Rinehart JS, Ruddock VE, Schiff I.  Treatment of premenstrual syndrome with alprazolam: results of a double-blind, placebo-controlled, randomized crossover clinical trial . Obstet Gynecol . 1987;;70:37-43.
19 +
Schmidt PJ, Grover GN, Rubinow DR.  Alprezolam in the treatment of premenstrual syndrome: a double-blind, placebo-controlled trial . Arch Gen Psychiatry . 1993;;50:467-473.
20 +
Menkes DB, Taghavi E, Mason PA, Spears GFS, Howard RC.  Fluoxetine treatment of severe premenstrual syndrome . BMJ . 1992;;305:346-347.
21 +
Steiner M, Steinberg S, Stewart D, et al.  Fluoxetine in the treatment of premenstrual dysphoria . N Engl J Med . 1995;;332:1529-1534.
22 +
Stone AB, Pearlstein TB, Brown WA.  Fluoxetine in the treatment of late luteal phase dysphoric disorder . J Clin Psychiatry . 1991;;52:290-293.
23 +
Wood SH, Mortola JF, Chan Yuen-F, Moossazadeh F, Yen SSC.  Treatment of premenstrual syndrome with fluoxetine: a double-blind, placebo-controlled, crossover study . Obstet Gynecol . 1992;;80:339-344.
24 +
Sundblad C, Modigh K, Andersch B, Eriksson E.  Clomipramine effectively reduces premenstrual irritability and dysphoria: a placebo-controlled trial . Acta Psychiatr Scand . 1992;;85:39-47.
25 +
Sundblad C, Hedberg MA, Eriksson E.  Clomipramine administered during the luteal phase reduces the symptoms of premenstrual syndrome: a placebo-controlled trial . Neuropsychopharmacology . 1993;;9:133-145.
26 +
Eriksson E, Hedberg MA, Andersch B, Sundblad C.  The serotonin reuptake inhibitor paroxetine is superior to the noradrenaline reuptake inhibitor maprotiline in the treatment of premenstrual syndrome . Neuropsychopharmacology .1995;;12:169-176.
27 +
Su T-P, Schmidt PJ, Danaceau MA, et al.  Fluoxetine in the treatment of premenstrual dysphoria . Neuropsychopharmacology . 1997;;16:346-356.
28 +
Endicott J, Harrison W. Daily Rating of Severity of Problems Form . New York, NY: Dept of Research Assessment and Training, New York State Psychiatric Institute; 1990;.
29 +
Endicott J, Nee J, Cohne J, Halbreich U.  Premenstrual changes: patterns and correlates of daily ratings . J Affect Disord . 1986;;10:127-135.
30 +
Williams JBW, Gibbon M, First MB, et al.  The Structured Clinical Interview for DSM-III-R (SCID), II: multisite test-retest reliability . Arch Gen Psychiatry . 1992;;49:630-636.
31 +
Hamilton M.  A rating scale for depression . J Neurol Neurosurg . 1960;;23:56-62.
32 +
Guy W. ECDEU Assessment Manual for Psychopharmacology . Revised 1st ed. Rockville, Md: US Dept of Health, Education and Welfare; 1976;.
33 +
Weissman MM, Bothwell S.  Assessment of social adjustment by patient self-report . Arch Gen Psychiatry . 1976;;33:1111-1115.
34 +
Statistical Analysis Software. Cary, NC: SAS Institute Inc; 1996.
35 +
Weissman MM, Prusoff BA, Thompson WD, Harding PS, Myers JK. Social adjustment by selfreport in a community sample and in psychiatric outpatients . J Nerv Ment Dis . 1978;;166:317-362.
36 +
Brzezinski AA, Wurtman JJ, Wurtman RJ, Gleason R, Greenfield J, Nader T.  D-Fenfluramine suppresses the increased calorie and carbohydrate intakes and improves the mood of women with premenstrual depression . Obstet Gynecol . 1990;;76:296-300.
37 +
Reimherr FW, Chouinard G, Cohn CK, et al.  Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled multicenter comparison study in outpatients with major depression . J Clin Psychiatry . 1990;;51( (12, suppl B) ):18-27.
38 +
Doogan DP, Caillard V.  Sertraline in the prevention of depression . Br J Psychiatry . 1992;;160:217-222.
39 +
Thase ME, Fava M, Halbreich U, et al.  A placebo-controlled randomized clinical trial comparing sertraline and imipramine for the treatment of dysthymia . Arch Gen Psychiatry . 1996;;53:777-784.
40 +
Pearlstein TB, Stone AB, Lund SA, Scheft H, Zlotnick C, Brown WA. A double-blind comparison of fluoxetine, buproprion and placebo in premenstrual dysphoric disorder. Presented at the annual meeting of the American Psychiatric Association, May 23, 1995, Miami, Fla. Abstract NR314.
41 +
Halbreich U, Tworek H.  Altered serotonergic activity in women with dysphoric premenstrual syndromes . Int J Psychiatry Med . 1993;;23:1-27.
42 +
Rapkin AJ.  The role of serotonin in premenstrual syndrome . Clin Obstet . 1992;;35:629-636.
43 +
Biegnon A, Reches A, Snyder L, McEwen BS.  Serotonergic and noradrenergic receptors in the rat brain: modulation of chronic exposure to ovarian hormones . Life Sci . 1983;;32:2015-2021.
44 +
Sumner BEH, Fink G.  Estrogen increases the density of 5-hydroxytryptamine-2A receptors in cerebral cortex and nucleus accumbens in the female rat . J Steroid Biochem Mol Biol . 1995;;54:15-20.
45 +
Harrison WM, Endicott J, Nee J, Glick H, Rabkin JG.  Characteristics of women seeking treatment for premenstrual syndrome . Psychosomatics . 1989;;30:405-411.
46 +
Stout AL, Steege JF, Blazer DG, George LK.  Comparison of lifetime diagnosis in premenstrual syndrome clinic and community samples . J Nerv Ment Dis . 1986;;174:517-521.
47 +
Pearlstein TB, Frank E, Rivera-Tovar A, Thoft JS, Jacobs E, Mieczkowski TA.  Prevalence of axis I and axis II disorders in women with late luteal phase dysphoric disorder . J Affect Disord . 1990;;20:129-134.
48 +
Yonkers KA, Gullion C, Williams A, Novak K, Rush AJ.  Paroxetine as a treatment for premenstrual dysphoric disorder . J Clin Psychopharmacol . 1996;;16:3-8.

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