Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women with Psychosis: Results from the DAAMSEL Clinical Trial

Deanna L. Kelly, Megan M. Powell, Heidi J. Wehring, MacKenzie A. Sayer, Ann Marie Kearns, Ann L. Hackman, Robert W. Buchanan, Rebecca B. Nichols, Heather A. Adams, Charles M. Richardson, Gopal Vyas, Robert P. McMahon, Amber K. Earl, Kelli M. Sullivan, Fang Liu, Sarah E. Luttrell, Faith B. Dickerson, Stephanie M. Feldman, Supriya Narang, Maju M. Koola & 3 others Peter F. Buckley, Jill A. Rachbeisel, Joseph Patrick McEvoy

Research output: Contribution to journalArticle

Abstract

Purpose/Background Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. Methods/Procedures Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5-15 mg/d). Participants had elevated prolactin (>24 ng/mL) and were experiencing galactorrhea, amenorrhea, oligomenorrhea, or sexual dysfunction on a prolactin-elevating antipsychotic. Participants were evaluated biweekly for prolactin elevation and galactorrhea and completed a menstrual diary review. Psychiatric symptoms and adverse effects were closely monitored. Findings/Results Forty-six women were randomized (n = 25 aripiprazole, n = 21 placebo). Thirty-seven completed at least 8 weeks of the study (n = 20 [80%] aripiprazole and n = 17 [81%] placebo). Aripiprazole (mean dose, 11.7 ± 2.4 mg/d) was effective for lowering prolactin relative to placebo (P = 0.04). In addition, 45% (9/20) of the aripiprazole group had a normalized prolactin (<24 mg/mL) compared with 12% (2/17) of the placebo group (P = 0.028). Galactorrhea resolved in 77% (10/13) of the aripiprazole-treated participants compared with 33% (4/12) in the placebo group (P = 0.028). Normalization of sexual function (<16 on the Arizona Sexual Experience Scale) occurred in 50% on aripiprazole (7/14) versus 9% (1/11) on placebo (P = 0.030). No differences between groups in symptoms or adverse effects were noted. Overall, women rated a mean score of 4.6 ± 0.6 on a 5-point Likert scale for sexual function improvement, suggesting their particular satisfaction with improvement in this domain. Implications/Conclusions Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis.

LanguageEnglish (US)
Pages317-326
Number of pages10
JournalJournal of Clinical Psychopharmacology
Volume38
Issue number4
DOIs
StatePublished - Aug 1 2018

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Prolactin
Psychotic Disorders
Clinical Trials
Placebos
Galactorrhea
Oligomenorrhea
Aripiprazole
Amenorrhea
Bipolar Disorder
Diagnostic and Statistical Manual of Mental Disorders
Antipsychotic Agents
Psychiatry
Schizophrenia
Health

Keywords

  • aripiprazole
  • clinical trial
  • prolactin
  • sexual dysfunction
  • women

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

Cite this

Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women with Psychosis : Results from the DAAMSEL Clinical Trial. / Kelly, Deanna L.; Powell, Megan M.; Wehring, Heidi J.; Sayer, MacKenzie A.; Kearns, Ann Marie; Hackman, Ann L.; Buchanan, Robert W.; Nichols, Rebecca B.; Adams, Heather A.; Richardson, Charles M.; Vyas, Gopal; McMahon, Robert P.; Earl, Amber K.; Sullivan, Kelli M.; Liu, Fang; Luttrell, Sarah E.; Dickerson, Faith B.; Feldman, Stephanie M.; Narang, Supriya; Koola, Maju M.; Buckley, Peter F.; Rachbeisel, Jill A.; McEvoy, Joseph Patrick.

In: Journal of Clinical Psychopharmacology, Vol. 38, No. 4, 01.08.2018, p. 317-326.

Research output: Contribution to journalArticle

Kelly, DL, Powell, MM, Wehring, HJ, Sayer, MA, Kearns, AM, Hackman, AL, Buchanan, RW, Nichols, RB, Adams, HA, Richardson, CM, Vyas, G, McMahon, RP, Earl, AK, Sullivan, KM, Liu, F, Luttrell, SE, Dickerson, FB, Feldman, SM, Narang, S, Koola, MM, Buckley, PF, Rachbeisel, JA & McEvoy, JP 2018, 'Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women with Psychosis: Results from the DAAMSEL Clinical Trial' Journal of Clinical Psychopharmacology, vol. 38, no. 4, pp. 317-326. https://doi.org/10.1097/JCP.0000000000000898
Kelly, Deanna L. ; Powell, Megan M. ; Wehring, Heidi J. ; Sayer, MacKenzie A. ; Kearns, Ann Marie ; Hackman, Ann L. ; Buchanan, Robert W. ; Nichols, Rebecca B. ; Adams, Heather A. ; Richardson, Charles M. ; Vyas, Gopal ; McMahon, Robert P. ; Earl, Amber K. ; Sullivan, Kelli M. ; Liu, Fang ; Luttrell, Sarah E. ; Dickerson, Faith B. ; Feldman, Stephanie M. ; Narang, Supriya ; Koola, Maju M. ; Buckley, Peter F. ; Rachbeisel, Jill A. ; McEvoy, Joseph Patrick. / Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women with Psychosis : Results from the DAAMSEL Clinical Trial. In: Journal of Clinical Psychopharmacology. 2018 ; Vol. 38, No. 4. pp. 317-326.
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abstract = "Purpose/Background Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. Methods/Procedures Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5-15 mg/d). Participants had elevated prolactin (>24 ng/mL) and were experiencing galactorrhea, amenorrhea, oligomenorrhea, or sexual dysfunction on a prolactin-elevating antipsychotic. Participants were evaluated biweekly for prolactin elevation and galactorrhea and completed a menstrual diary review. Psychiatric symptoms and adverse effects were closely monitored. Findings/Results Forty-six women were randomized (n = 25 aripiprazole, n = 21 placebo). Thirty-seven completed at least 8 weeks of the study (n = 20 [80{\%}] aripiprazole and n = 17 [81{\%}] placebo). Aripiprazole (mean dose, 11.7 ± 2.4 mg/d) was effective for lowering prolactin relative to placebo (P = 0.04). In addition, 45{\%} (9/20) of the aripiprazole group had a normalized prolactin (<24 mg/mL) compared with 12{\%} (2/17) of the placebo group (P = 0.028). Galactorrhea resolved in 77{\%} (10/13) of the aripiprazole-treated participants compared with 33{\%} (4/12) in the placebo group (P = 0.028). Normalization of sexual function (<16 on the Arizona Sexual Experience Scale) occurred in 50{\%} on aripiprazole (7/14) versus 9{\%} (1/11) on placebo (P = 0.030). No differences between groups in symptoms or adverse effects were noted. Overall, women rated a mean score of 4.6 ± 0.6 on a 5-point Likert scale for sexual function improvement, suggesting their particular satisfaction with improvement in this domain. Implications/Conclusions Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis.",
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TY - JOUR

T1 - Adjunct Aripiprazole Reduces Prolactin and Prolactin-Related Adverse Effects in Premenopausal Women with Psychosis

T2 - Journal of Clinical Psychopharmacology

AU - Kelly, Deanna L.

AU - Powell, Megan M.

AU - Wehring, Heidi J.

AU - Sayer, MacKenzie A.

AU - Kearns, Ann Marie

AU - Hackman, Ann L.

AU - Buchanan, Robert W.

AU - Nichols, Rebecca B.

AU - Adams, Heather A.

AU - Richardson, Charles M.

AU - Vyas, Gopal

AU - McMahon, Robert P.

AU - Earl, Amber K.

AU - Sullivan, Kelli M.

AU - Liu, Fang

AU - Luttrell, Sarah E.

AU - Dickerson, Faith B.

AU - Feldman, Stephanie M.

AU - Narang, Supriya

AU - Koola, Maju M.

AU - Buckley, Peter F.

AU - Rachbeisel, Jill A.

AU - McEvoy, Joseph Patrick

PY - 2018/8/1

Y1 - 2018/8/1

N2 - Purpose/Background Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. Methods/Procedures Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5-15 mg/d). Participants had elevated prolactin (>24 ng/mL) and were experiencing galactorrhea, amenorrhea, oligomenorrhea, or sexual dysfunction on a prolactin-elevating antipsychotic. Participants were evaluated biweekly for prolactin elevation and galactorrhea and completed a menstrual diary review. Psychiatric symptoms and adverse effects were closely monitored. Findings/Results Forty-six women were randomized (n = 25 aripiprazole, n = 21 placebo). Thirty-seven completed at least 8 weeks of the study (n = 20 [80%] aripiprazole and n = 17 [81%] placebo). Aripiprazole (mean dose, 11.7 ± 2.4 mg/d) was effective for lowering prolactin relative to placebo (P = 0.04). In addition, 45% (9/20) of the aripiprazole group had a normalized prolactin (<24 mg/mL) compared with 12% (2/17) of the placebo group (P = 0.028). Galactorrhea resolved in 77% (10/13) of the aripiprazole-treated participants compared with 33% (4/12) in the placebo group (P = 0.028). Normalization of sexual function (<16 on the Arizona Sexual Experience Scale) occurred in 50% on aripiprazole (7/14) versus 9% (1/11) on placebo (P = 0.030). No differences between groups in symptoms or adverse effects were noted. Overall, women rated a mean score of 4.6 ± 0.6 on a 5-point Likert scale for sexual function improvement, suggesting their particular satisfaction with improvement in this domain. Implications/Conclusions Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis.

AB - Purpose/Background Prolactin-related adverse effects contribute to nonadherence and adverse health consequences, particularly in women with severe mental illness. Treating these adverse effects may improve treatment acceptability, adherence, and long-term outcomes. Methods/Procedures Premenopausal women with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder were recruited for a randomized, double-blind, placebo-controlled 16-week trial of adjunct aripiprazole (5-15 mg/d). Participants had elevated prolactin (>24 ng/mL) and were experiencing galactorrhea, amenorrhea, oligomenorrhea, or sexual dysfunction on a prolactin-elevating antipsychotic. Participants were evaluated biweekly for prolactin elevation and galactorrhea and completed a menstrual diary review. Psychiatric symptoms and adverse effects were closely monitored. Findings/Results Forty-six women were randomized (n = 25 aripiprazole, n = 21 placebo). Thirty-seven completed at least 8 weeks of the study (n = 20 [80%] aripiprazole and n = 17 [81%] placebo). Aripiprazole (mean dose, 11.7 ± 2.4 mg/d) was effective for lowering prolactin relative to placebo (P = 0.04). In addition, 45% (9/20) of the aripiprazole group had a normalized prolactin (<24 mg/mL) compared with 12% (2/17) of the placebo group (P = 0.028). Galactorrhea resolved in 77% (10/13) of the aripiprazole-treated participants compared with 33% (4/12) in the placebo group (P = 0.028). Normalization of sexual function (<16 on the Arizona Sexual Experience Scale) occurred in 50% on aripiprazole (7/14) versus 9% (1/11) on placebo (P = 0.030). No differences between groups in symptoms or adverse effects were noted. Overall, women rated a mean score of 4.6 ± 0.6 on a 5-point Likert scale for sexual function improvement, suggesting their particular satisfaction with improvement in this domain. Implications/Conclusions Building upon prior studies, this rigorous evaluation confirms the utility of adjunctive aripiprazole as a strategy for improving prolactin and managing prolactin-related adverse effects in premenopausal women with psychosis.

KW - aripiprazole

KW - clinical trial

KW - prolactin

KW - sexual dysfunction

KW - women

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