Atomoxetine, Placebo and Parent Management Training in Autism

NCT ID: NCT00844753

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2014-04-30

Brief Summary

The study will evaluate the effectiveness of atomoxetine (Strattera) with and without Parent Management Training (PMT) in children with Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDDNOS) who have symptoms of Attention Deficit Hyperactivity Disorder (ADHD). This is a double-blind placebo, parallel study where the atomoxetine will have a dose titration over a 6 week period. All children will be seen weekly during this titration period, with additional visits at Week 8 and Week 10. Families assigned to the PMT arm will have an additional weekly meeting with a clinician for a total of 9 PMT visits. PMT involves teaching parents to implement behavioral interventions with their children. Subjects who are clinical responders (ADHD Responders and Compliance Responders) from the 10 week study period will be followed every 4 weeks in a 24-week extension study. Subjects who are clinical nonresponders will continue in PMT if they received PMT during the double-blind phase, and they will receive an open trial of atomoxetine if they were on placebo during the double-blind phase. All subjects (responders and nonresponders) will be invited to participate in follow-up assessments every 4 weeks for 24 weeks after the completion of the double-blind phase.

Conditions

Autism; Pervasive Development Disorder; Asperger's Disorder; Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Atomoxetine + Parent Management Training

Group Type: ACTIVE_COMPARATOR

atomoxetine

Intervention Type: DRUG

atomoxetine

Parent Management Training

Intervention Type: BEHAVIORAL

2

Atomoxetine without Parent Management Training

Group Type: ACTIVE_COMPARATOR

atomoxetine

Intervention Type: DRUG

atomoxetine

3

Placebo + Parent Management Training

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo + parent management treatment

Parent Management Training

Intervention Type: BEHAVIORAL

4

Placebo without Parent Management Training

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo + parent management treatment

Interventions

atomoxetine

atomoxetine

Intervention Type: DRUG

Placebo

Placebo + parent management treatment

Intervention Type: DRUG

Parent Management Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children 5 yrs to 14 years 11 mos with clinical diagnosis of Autism, Asperger's Disorder, or PDDNOS based upon the ADI-R and clinical evaluation by DSM-IV criteria,
• Mental age equal to or greater than 24 months,
• ADHD symptoms based upon the CASI and clinical confirmed diagnosis,
• CGIS-S rating of 4 or grater for ADHD symptoms,
• A mean item score of >1.5 on both the Parent and Teacher (non-parent caregiver) SNAP-IV 18 ADHD symptoms or the 9-symptom hyperactive-impulsive subscale (symptoms must be cross-situational),
• Reliable care provider available to bring subject to clinic visits and weekly sessions.

Exclusion Criteria

• DSM-IV diagnosis of schizophrenia, schizoaffective disorder psychotic disorder NOS,bipolar disorder, or major depression (if accompanied by a family history of bipolar disorder) based upon evidence of suicidality, CASI, and clinical interview/history,
• Prior failed adequate trial of atomoxetine,
• Use of other psychotropic medications that produce CNS effects,
• Diagnosis of bipolar disorder, major depression, hypertension, cardiovascular disease, narrow angle glaucoma, other significant physical illness,
• Pregnancy or sexually active females (intercourse in the past 6 months, reported by either the subject or caregiver),
• Currently on effective medication treatment for ADHD,
• Prior involvement in Parent Management Training or other similar program,
• Currently on albuterol or taking beta blockers,
• Taking supplements or other complementary medical treatments where dose cannot be held at current level for duration of study

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

tristram smith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Benjamin Handen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Michael Aman, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Tristram Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Ohio State University

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

References

Chowdhury M, Aman MG, Scahill L, Swiezy N, Arnold LE, Lecavalier L, Johnson C, Handen B, Stigler K, Bearss K, Sukhodolsky D, McDougle CJ. The Home Situations Questionnaire-PDD version: factor structure and psychometric properties. J Intellect Disabil Res. 2010 Mar;54(3):281-91. doi: 10.1111/j.1365-2788.2010.01259.x.

Reference Type: RESULT

PMID: 20377705 (View on PubMed)

Barkley, R. A., & Edelbrock, C. (1987). Assessing situational variation in children's problem behaviors: The Home and School Situations Questionnaires. In R. Prinz (Ed.), Advances in behavioral assessment of children and families (pp. 157-176). Greenwich, CT: JAI Press Inc

Reference Type: RESULT

Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Arnold LE, Ober N, Aman MG, Handen B, Smith T, Pan X, Hyman SL, Hollway J, Lecavalier L, Page K, Rice R Jr. A 1.5-Year Follow-Up of Parent Training and Atomoxetine for Attention-Deficit/Hyperactivity Disorder Symptoms and Noncompliant/Disruptive Behavior in Autism. J Child Adolesc Psychopharmacol. 2018 Jun;28(5):322-330. doi: 10.1089/cap.2017.0134. Epub 2018 Apr 25.

Reference Type: DERIVED

PMID: 29694241 (View on PubMed)

Lecavalier L, Pan X, Smith T, Handen BL, Arnold LE, Silverman L, Tumuluru RV, Hollway J, Aman MG. Parent Stress in a Randomized Clinical Trial of Atomoxetine and Parent Training for Children with Autism Spectrum Disorder. J Autism Dev Disord. 2018 Apr;48(4):980-987. doi: 10.1007/s10803-017-3345-4.

Reference Type: DERIVED

PMID: 29022125 (View on PubMed)

Smith T, Aman MG, Arnold LE, Silverman LB, Lecavalier L, Hollway J, Tumuluru R, Hyman SL, Buchan-Page KA, Hellings J, Rice RR Jr, Brown NV, Pan X, Handen BL. Atomoxetine and Parent Training for Children With Autism and Attention-Deficit/Hyperactivity Disorder: A 24-Week Extension Study. J Am Acad Child Adolesc Psychiatry. 2016 Oct;55(10):868-876.e2. doi: 10.1016/j.jaac.2016.06.015. Epub 2016 Aug 2.

Reference Type: DERIVED

PMID: 27663942 (View on PubMed)

Handen BL, Aman MG, Arnold LE, Hyman SL, Tumuluru RV, Lecavalier L, Corbett-Dick P, Pan X, Hollway JA, Buchan-Page KA, Silverman LB, Brown NV, Rice RR Jr, Hellings J, Mruzek DW, McAuliffe-Bellin S, Hurt EA, Ryan MM, Levato L, Smith T. Atomoxetine, Parent Training, and Their Combination in Children With Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry. 2015 Nov;54(11):905-15. doi: 10.1016/j.jaac.2015.08.013. Epub 2015 Sep 3.

Reference Type: DERIVED

PMID: 26506581 (View on PubMed)

Other Identifiers

1R01MH079082-01A2

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00699205

Identifier Type: -

Identifier Source: nct_alias