The SOFIA Study: Negative Multi-center Study of Low Dose Fluoxetine on Repetitive Behaviors in Children and Adolescents with Autistic Disorder

被引:35
作者
Herscu, Paul [1 ,2 ]
Handen, Benjamin L. [3 ]
Arnold, L. Eugene [4 ]
Snape, Michael F. [2 ,5 ]
Bregman, Joel D. [6 ,7 ]
Ginsberg, Lawrence [8 ]
Hendren, Robert [9 ,10 ]
Kolevzon, Alexander [11 ]
Melmed, Raun [12 ]
Mintz, Mark [13 ,14 ]
Minshew, Nancy [15 ]
Sikich, Linmarie [16 ,17 ]
Attalla, Ashraf [18 ]
King, Brian [19 ,20 ]
Owley, Thomas [21 ]
Childress, Ann [22 ]
Chugani, Harry [23 ,24 ]
Frazier, Jean [25 ,26 ]
Cartwright, Charles [27 ]
Murphy, Tanya [28 ,29 ]
机构
[1] Herscu Lab & Consulting LLC, 356 Middle St, Amherst, MA USA
[2] Neuropharm PLC, London, England
[3] Univ Pittsburgh, Sch Med, 1011 Bingham St, Pittsburgh, PA 15203 USA
[4] Ohio State Univ, Nisonger Ctr UCEDD, McCampbell Hall,1581 Dodd Dr, Columbus, OH USA
[5] AMO Pharma Ltd, Throwsters St, Wonersh GU5 0PF, England
[6] United Community & Family Serv Healthcare, Ctr Autism & Neurodev Disorders, 47 Town St, Norwich, CT 06360 USA
[7] North Shore Long Isl Jewish Hlth Syst, New Hyde Pk, NY USA
[8] Red Oak Psychiat Associates, 15115 Red Oak Dr 109, Houston, TX USA
[9] Univ Calif San Francisco, 401 Parnassus Ave,Box 0984, San Francisco, CA 94143 USA
[10] Univ Calif Davis, Sacramento, CA 95817 USA
[11] Mt Sinai Sch Med, Icahn Sch Med Mt Sinai, Seaver Autism Ctr Res & Treatment, Dept Psychiat, One Gustave L Levy Pl,Box 1230, New York, NY USA
[12] Southwest Autism Res & Resource Ctr, 300 N 18th St, Phoenix, AZ USA
[13] Ctr Neurol & Neurodev Hlth, 2050 Voorhees Town Ctr, Voorhees, NJ USA
[14] Clin Res Ctr New Jersey, 2050 Voorhees Town Ctr, Voorhees, NJ USA
[15] Univ Pittsburgh, Sch Med, 3811 OHara St, Pittsburgh, PA USA
[16] Duke Univ, Duke Ctr Autism & Brain Dev, Med Sch, 2608 Erwin Rd,Suite 300, Durham, NC USA
[17] Univ N Carolina, Chapel Hill, NC 27515 USA
[18] Inst Behav Med, 696 Concord Rd SE, Smyrna, GA USA
[19] Univ Calif San Francisco, UCSF Weill Inst Neurosci, 401 Parnassus Ave,Suite LP 358, San Francisco, CA 94143 USA
[20] Univ Washington, Seattle, WA 98195 USA
[21] Univ Illinois, Coll Med, 1835 W Polk St, Chicago, IL USA
[22] Ctr Psychiat & Behav Med Inc, 7351 Prairie Falcon Rd,Suite 160, Las Vegas, NV 89128 USA
[23] NYU, Langone Comprehens Epilepsy Ctr, 223 East 34th St, New York, NY USA
[24] Childrens Hosp Michigan, Detroit, MI 48201 USA
[25] Univ Massachusetts, Med Ctr, 55 Lake Ave North, Worcester, MA 01655 USA
[26] Cambridge Hlth Alliance, Cambridge, MA USA
[27] Spectrum Hlth Associates, 210 Bellevue Ave, Montclair, NJ USA
[28] Univ S Florida, Rothman Ctr Pediat Neuropsychiat, 880 6th St South, St Petersburg, FL USA
[29] Univ Florida, Gainesville, FL USA
关键词
Autism spectrum disorder; Repetitive behavior; Selective seretonin reuptake inhibitor; SEROTONIN TRANSPORTER OCCUPANCY; OBSESSIVE-COMPULSIVE DISORDER; PLACEBO-CONTROLLED TRIAL; SELF-STIMULATION; DOUBLE-BLIND; REUPTAKE INHIBITORS; SPECTRUM DISORDERS; CROSSOVER TRIAL; YOUNG-PEOPLE; ADULTS;
D O I
10.1007/s10803-019-04120-y
中图分类号
B844 [发展心理学(人类心理学)];
学科分类号
040202 ;
摘要
Fluoxetine is a selective serotonin reuptake inhibitor (SSRI) that reduces obsessive-compulsive symptoms. There is limited evidence supporting its efficacy for repetitive behaviors (RRBs) in autistic spectrum disorder (ASD). We conducted a randomized controlled trial (RCT) of fluoxetine in 158 individuals with ASD (5-17 years). Following 14 treatment weeks (mean dose 11.8 mg/day), no significant differences were noted on the Children's Yale-Brown Obsessive Compulsive Scale; the proportion of responders was similar (fluoxetine: 36%; placebo: 41%). There were similar rates of AEs (e.g., insomnia, diarrhea, vomiting); high rates of activation were reported in both groups (fluoxetine: 42%; placebo: 45%). Overly cautious dosing/duration may have prevented attainment of a therapeutic level. Results are consistent with other SSRI RCTs treating RRBs in ASD. Trial Registration: clinicaltrials.gov Identifier: NCT00515320.
引用
收藏
页码:3233 / 3244
页数:12
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