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Atomoxetine, Placebo and Parent Management Training in Autism (Strattera)

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ClinicalTrials.gov Identifier: NCT00844753
Recruitment Status : Completed
First Posted : February 16, 2009
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
University of Pittsburgh
Ohio State University
Information provided by (Responsible Party):
tristram smith, University of Rochester

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions: Autism
Pervasive Development Disorder
Asperger's Disorder
Attention Deficit Hyperactivity Disorder
Interventions: Drug: atomoxetine
Drug: Placebo
Behavioral: Parent Management Training

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
200 participants were screened. 131 passed screening. Participants failed screening for the following reasons: 16 Attention Deficit Hyperactivity Disorder (ADHD) not confirmed, 23 Autism Spectrum Disorder not confirmed, 7 previous parent therapy or mental age too low, 23 for other reasons.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Two participants who passed screening withdrew and one child became ineligible because of ADHD severity declining at baseline.

Reporting Groups
  Description
Atomoxetine (ATX) + Parent Management Training

ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.

Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing.

Atomoxetine (ATX) Without Parent Management Training ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Placebo + Parent Management Training

Sugar pill administered twice daily

Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing.

Placebo Without Parent Management Training Sugar pill administered twice daily.

Participant Flow:   Overall Study
    Atomoxetine (ATX) + Parent Management Training   Atomoxetine (ATX) Without Parent Management Training   Placebo + Parent Management Training   Placebo Without Parent Management Training
STARTED   32   32   32   32 
COMPLETED   24   29   25   21 
NOT COMPLETED   8   3   7   11 
Lack of Efficacy                1                0                2                2 
Adverse Event                3                2                5                5 
Lost to Follow-up                1                1                0                1 
could not swallow medication                2                0                0                0 
Withdrawal by Subject                1                0                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atomoxetine + Parent Management Training

ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.

Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing.

Atomoxetine Without Parent Management Training ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
Placebo + Parent Management Training

Sugar pill administered twice daily

Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing.

Placebo Without Parent Management Training Sugar pill administered twice daily.
Total Total of all reporting groups

Baseline Measures
   Atomoxetine + Parent Management Training   Atomoxetine Without Parent Management Training   Placebo + Parent Management Training   Placebo Without Parent Management Training   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   32   32   32   128 
Age 
[Units: Years]
Mean (Standard Deviation)
 8.0  (1.9)   8.6  (2.3)   7.7  (1.5)   8.2  (2.4)   8.1  (2.1) 
Gender 
[Units: Participants]
         
Female   1   6   5   8   20 
Male   31   26   27   24   108 
Region of Enrollment 
[Units: Participants]
         
United States   32   32   32   32   128 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents   [ Time Frame: week 10 ]

2.  Primary:   Percentage of Participants Who Were Autism Spectrum Disorder Respondents   [ Time Frame: week 10 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ben Handen
Organization: University of Pittsburgh
phone: 412-235-5452
e-mail: HandenBL@upmc.edu


Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: tristram smith, University of Rochester
ClinicalTrials.gov Identifier: NCT00844753     History of Changes
Obsolete Identifiers: NCT00699205
Other Study ID Numbers: 1R01MH079082-01A2 ( U.S. NIH Grant/Contract )
First Submitted: June 6, 2008
First Posted: February 16, 2009
Results First Submitted: November 23, 2015
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016