Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
This study is currently recruiting participants.
Verified October 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Christopher John McDougle, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01302964
First received: August 25, 2010
Last updated: October 22, 2012
Last verified: October 2012
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Purpose
This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
| Condition | Intervention | Phase |
|---|---|---|
|
Autism Spectrum Disorders |
Drug: Placebo Drug: Mirtazapine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders |
Resource links provided by NLM:
Drug Information available for:
Mirtazapine
Ziprasidone hydrochloride
Ziprasidone
Ziprasidone mesylate
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Collected at screen (Visit 1) baseline (Visit 2) and endpoint (Week 10) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]The CGI is designed to take into account all factors to arrive at an assessment of severity and response to treatment.
| Estimated Enrollment: | 30 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Mirtazapine
The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
|
Drug: Mirtazapine
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: Geodon
Drug: 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.
|
Drug: Placebo
Subjects randomized to placebo will receive placebo for duration of the study
Other Name: Sugar pill
|
Detailed Description:
One of the areas receiving very little attention in Pervasive Developmental Disorders (PDDs) is that of anxiety. Anxiety is common in PDD, but has not yet been fully characterized. The primary objective of this study is to conduct a preliminary placebo-controlled trial of mirtazapine for the treatment of anxiety associated with PDDs. We hypothesize that mirtazapine will be safe and well tolerated.
Eligibility| Ages Eligible for Study: | 5 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ages 5-17 years
- Diagnosis of autistic disorder, Asperger's disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD NOS)
- Clinically significant anxiety as evidenced by a Pediatric Anxiety Rating Scale (PARS) score of 10 or greater
- Abbreviated intelligence quotient (IQ) greater than 50 on the Stanford Binet 5th Ed.
Exclusion Criteria:
- Diagnosis of Rett's disorder or childhood integrative disorder.
- Diagnosis of obsessive-compulsive disorder (OCD), post-traumatic stress disorder, major mood disorder, psychotic disorder, or substance use disorder
- Presence of any past or present medical conditions that would make treatment with mirtazapine unsafe
- Use of other antidepressants or benzodiazepines
- Use of other psychotropic medications which are ineffective, poorly tolerated, or sub-optimal in terms of dose.
- Previous adequate trial of mirtazapine.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302964
Contacts
| Contact: Jennifer Mullett, RN,CCRP | 781-860-1711 | LurieCenterResearch@partners.org |
Locations
| 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 | |
Sponsors and Collaborators
Massachusetts General Hospital
Autism Speaks
Investigators
| Principal Investigator: | Christopher J. McDougle, M.D. | Indiana University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Christopher John McDougle, M.D., Director, Lurie Center for Autism, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01302964 History of Changes |
| Other Study ID Numbers: | 2012P00009 |
| Study First Received: | August 25, 2010 |
| Last Updated: | October 22, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Autistic Disorder Asperger's Disorder Pervasive Developmental Disorder |
Additional relevant MeSH terms:
|
Autistic Disorder Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood Mental Disorders Mirtazapine Mianserin Antidepressive Agents, Tricyclic Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Serotonin Antagonists Serotonin Agents Antidepressive Agents, Second-Generation |
ClinicalTrials.gov processed this record on June 18, 2013