Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
|ClinicalTrials.gov Identifier: NCT01302964|
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Placebo Drug: Mirtazapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||October 10, 2017|
|Actual Study Completion Date :||October 10, 2017|
The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.
Other Name: Remeron
Placebo Comparator: Placebo
Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients.
Subjects randomized to placebo will receive placebo for duration of the study
Other Name: Sugar pill
- Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase [ Time Frame: Weeks Baseline, 2, 4, 6, and 10 ]The Pediatric Anxiety Rating Scale (PARS) is a clinician-rated instrument that assesses anxiety symptoms that are commonly associated with social anxiety, separation anxiety, and generalized anxiety disorders. Scaled score ranges form 0-25 with higher scores indicating more severe anxiety symptoms. Means were estimated using a repeated measures linear regression model with treatment group, study week (in categories), and their interaction as covariates, and assuming a common mean between treatment groups at baseline. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes.
- Proportion of Participants Who Responded to Treatment at 10 Weeks According to the Improvement Item of the Clinical Global Impression-Scale (Response Defined as CGI-I=1 or CGI-I=2) [ Time Frame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) ]The Clinical Global Impressions Global Improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7 (1=very much improved; 2= much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse), with lower scores indicating improvement (1=very much improved and 2=much improved). In this study the CGI was focused on the target symptom of anxiety. Participants with a CGI-I score of 1 or 2 were classified as responders. The CGI-I was administered biweekly for 6 weeks and again at 10 weeks during the study. The participant who withdrew from the study before 10 weeks was not included in the calculations.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302964
|United States, Indiana|
|Riley Child and Adolescent Psychiatry Clinic Riley Hospital|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Lurie Center -MassGeneral Hospital|
|Lexington, Massachusetts, United States, 02421|
|Principal Investigator:||Christopher J. McDougle, M.D.||Indiana University School of Medicine|