Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
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|ClinicalTrials.gov Identifier: NCT01302964|
Recruitment Status : Recruiting
First Posted : February 24, 2011
Last Update Posted : August 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorders||Drug: Placebo Drug: Mirtazapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated 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|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2018|
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 weekly for subject weighing less than 5 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability.
Other Name: GeodonDrug: Mirtazapine
Subjects will receive 7.5 mg of mirtazapine daily initially. The dose will be increased by 7.5 mg for subjects weighing less than 50kg and up to 15 mg per week for subjects weighing more than 50kg. depending upon efficacy and tolerability.
Other Name: Geodon
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
- Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Collected at screen (Visit 1) baseline (Visit 2) and endpoint (Week 10) ]Assesses severity across common anxiety disorders in children including generalized anxiety, social anxiety, separation anxiety and transition-associated anxiety.
- Clinical Global Impressions (CGI) [ Time Frame: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) ]The CGI is designed to take into account all factors to arrive at an assessment of severity and response to treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302964
|Contact: Jennifer Mullett, RN,CCRP||781-860-1711||LurieCenterResearch@partners.org|
|United States, Indiana|
|Riley Child and Adolescent Psychiatry Clinic Riley Hospital||Completed|
|Indianapolis, Indiana, United States, 46202|
|United States, Massachusetts|
|Lurie Center -MassGeneral Hospital||Recruiting|
|Lexington, Massachusetts, United States, 02421|
|Contact: Jennifer Mullett, RN,CCRP 781-860-1711 LurieCenterResearch@partners.org|
|Principal Investigator: Christopher J McDougle, MD|
|Principal Investigator:||Christopher J. McDougle, M.D.||Indiana University School of Medicine|