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A prospective open-label study of aripiprazole in fragile X syndrome.
Psychopharmacology (Berl). 2011 Jul; 216(1):85-90.P

Abstract

RATIONALE

Fragile X syndrome (FXS) is the most common inherited form of developmental disability and most common single gene cause of autism. Persons with FXS frequently exhibit irritable behavior marked by aggression, self-injury, and severe tantrums. Despite frequent clinical use of atypical antipsychotic drugs to target this behavioral cluster, no systematic trials to date have assessed the efficacy and safety of these drugs in persons with FXS.

METHODS

We conducted a prospective open-label 12-week trial of aripiprazole in 12 persons aged 6-25 years (mean age, 14.3 years) with FXS who were free of concomitant psychoactive drugs.

RESULTS

Aripiprazole use (mean dose, 9.8 mg/day) was associated with treatment response (defined by a Clinical Global Impressions-Improvement scale score of much improved or very much improved and a ≥ 25% improvement on the Aberrant Behavior Checklist-Irritability subscale) in 10 of 12 (87%) persons. Two individuals (13%) discontinued aripiprazole prior to study completion due to adverse events. One discontinuation was due to akathisia, mild drooling, and mild tiredness and the other due to moderate tiredness and moderate drooling. No significant changes in vital signs including weight or laboratory measures occurred during treatment with aripiprazole.

CONCLUSIONS

Aripiprazole was generally safe and well tolerated and was associated with significant improvement in irritable behavior. Given these findings, a double-blind, placebo-controlled study of aripiprazole in FXS is warranted.

Authors+Show Affiliations

Department of Psychiatry, Indiana University School of Medicine, 702 Barnhill Drive, Indianapolis, IN 46202, USA. crericks@iupui.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21318565

Citation

Erickson, Craig A., et al. "A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome." Psychopharmacology, vol. 216, no. 1, 2011, pp. 85-90.
Erickson CA, Stigler KA, Wink LK, et al. A prospective open-label study of aripiprazole in fragile X syndrome. Psychopharmacology (Berl). 2011;216(1):85-90.
Erickson, C. A., Stigler, K. A., Wink, L. K., Mullett, J. E., Kohn, A., Posey, D. J., & McDougle, C. J. (2011). A prospective open-label study of aripiprazole in fragile X syndrome. Psychopharmacology, 216(1), 85-90. https://doi.org/10.1007/s00213-011-2194-7
Erickson CA, et al. A Prospective Open-label Study of Aripiprazole in Fragile X Syndrome. Psychopharmacology (Berl). 2011;216(1):85-90. PubMed PMID: 21318565.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A prospective open-label study of aripiprazole in fragile X syndrome. AU - Erickson,Craig A, AU - Stigler,Kimberly A, AU - Wink,Logan K, AU - Mullett,Jennifer E, AU - Kohn,Arlene, AU - Posey,David J, AU - McDougle,Christopher J, Y1 - 2011/02/12/ PY - 2010/12/05/received PY - 2011/01/18/accepted PY - 2011/2/15/entrez PY - 2011/2/15/pubmed PY - 2011/11/9/medline SP - 85 EP - 90 JF - Psychopharmacology JO - Psychopharmacology (Berl.) VL - 216 IS - 1 N2 - RATIONALE: Fragile X syndrome (FXS) is the most common inherited form of developmental disability and most common single gene cause of autism. Persons with FXS frequently exhibit irritable behavior marked by aggression, self-injury, and severe tantrums. Despite frequent clinical use of atypical antipsychotic drugs to target this behavioral cluster, no systematic trials to date have assessed the efficacy and safety of these drugs in persons with FXS. METHODS: We conducted a prospective open-label 12-week trial of aripiprazole in 12 persons aged 6-25 years (mean age, 14.3 years) with FXS who were free of concomitant psychoactive drugs. RESULTS: Aripiprazole use (mean dose, 9.8 mg/day) was associated with treatment response (defined by a Clinical Global Impressions-Improvement scale score of much improved or very much improved and a ≥ 25% improvement on the Aberrant Behavior Checklist-Irritability subscale) in 10 of 12 (87%) persons. Two individuals (13%) discontinued aripiprazole prior to study completion due to adverse events. One discontinuation was due to akathisia, mild drooling, and mild tiredness and the other due to moderate tiredness and moderate drooling. No significant changes in vital signs including weight or laboratory measures occurred during treatment with aripiprazole. CONCLUSIONS: Aripiprazole was generally safe and well tolerated and was associated with significant improvement in irritable behavior. Given these findings, a double-blind, placebo-controlled study of aripiprazole in FXS is warranted. SN - 1432-2072 UR - https://www.unboundmedicine.com/medline/citation/21318565/A_prospective_open_label_study_of_aripiprazole_in_fragile_X_syndrome_ L2 - https://dx.doi.org/10.1007/s00213-011-2194-7 DB - PRIME DP - Unbound Medicine ER -