Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorders

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
Mclean Hospital
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01972074
First received: October 24, 2013
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

This study is a 12-week randomized-controlled trial of memantine hydrochloride (Namenda) for the treatment for social impairment in adolescents with autism spectrum disorders (ASD). The investigators will also conduct pre- and post-treatment neuroimaging (fMRI and HMRS) to assess neural functional deficits in adolescents in ASD compared to healthy volunteer adolescents and to assess any effects of memantine therapy on neural function in adolescents with ASD. The investigators hypothesize that short-term memantine monotherapy will be safe, well-tolerated, and effective in improving the core symptoms of autism spectrum disorders in adolescents with ASD. Additionally, the investigators hypothesize that following memantine therapy, ASD subjects will exhibit a decrease in glutamate (Glu) concentration in the anterior-cingulate cortex (ACC) and a change towards normalization in altered functional connectivity of the ACC and medial temporal lobes, consistent with improvement in social impairments in ASD. The investigators hypothesize that compared to healthy volunteer subjects, ASD subjects will significantly differ on neuroimaging measures at baseline but that following memantine therapy, the difference between ASD and healthy volunteer neuroimaging data will decrease.


Condition Intervention Phase
Autism Spectrum Disorder
Drug: Memantine
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: Behavioral and Neural Response to Memantine in Adolescents With Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Aberrant Behavior Checklist-Social Withdrawal Subscale [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The Aberrant Behavior Checklist is a 58-item scale completed by the parent and reviewed by a clinician to establish the frequency of problematic or abnormal behaviors


Estimated Enrollment: 90
Study Start Date: September 2014
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects in the placebo control group will receive a matched placebo pill with no active ingredients. This will be administered twice daily for 12 weeks.
Experimental: Memantine
Memantine administered in tablet form twice daily titrated to a maximum dose of 20 mg for 12 weeks
Drug: Memantine
Tablet
Other Name: Namenda
No Intervention: Control Group
Healthy volunteers will be scanned twice (12 weeks apart) and will receive no intervention.

  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male & female ages 13-17 yrs.
  2. Tanner stage of ≥III (by Petersen Pubertal Development Scale).

    Participants with ASDs

  3. Diagnostic and Statistical Manual Fourth Edition (Text Revision) DSM-IV-TR PDD diagnostic criteria for autistic disorder, Asperger's disorder, or Pervasive Developmental Disorder -Not Otherwise Specified as established by clinical diagnostic interview.
  4. At least moderate severity of social impairment as measured by a score of ≥14 on the caregiver (parent/guardian) completed Social Withdrawal subscale of the Aberrant Behavior Checklist (ABC-SW) and a score of ≥4 on the clinician administered Clinical Global Impression-Severity scale.
  5. Psychotropic medication-free for ≥4 weeks prior to trial participation.

Healthy Control Participants 3. Age-, sex-, & Intelligence Quotient (IQ)-matched. 4. No Axis I diagnoses as established by the Kiddie Schedule for Affective Disorders- Epidemiological Version (K-SADS-E) & confirmed by clinical diagnostic interview.

5. No significant traits of ASDs as screened by Social Responsiveness Scale (SRS)(raw score <60).

Exclusion Criteria:

  1. IQ ≤85
  2. Impaired communicative speech
  3. Subjects currently treated with medication with primary central nervous system activity that are unwilling to withhold medication for 48 hours prior to scan.
  4. Contraindications to Magnetic Resonance scanning (claustrophobia, braces, metal in the body, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972074

Contacts
Contact: Stephannie Furtak, BA 617-724-2344 sfurtak1@partners.org
Contact: Rebecca Grossman, BA 617-643-1432 Rgossman1@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Stephannie Furtak, BA    617-724-2344    Sfurtak1@partners.org   
Contact: Rebecca Grossman, BA    617-643-1432    rgrossman1@partners.org   
Principal Investigator: Gagan Joshi, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Mclean Hospital
Investigators
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Gagan Joshi, MD, Associate Professor of Psychiatry, Harvard Medical School; Director, Bressler Program for Autism Spectrum Disorders, Pediatric Psychopharmacology, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01972074     History of Changes
Other Study ID Numbers: 2013-P-001826
Study First Received: October 24, 2013
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Autism spectrum disorder
Treatment
Adolescents
Memantine
functional Magnetic Resonance Imaging
MRS
Neuroimaging

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents

ClinicalTrials.gov processed this record on September 11, 2014