Study of Neuroimaging Biomarkers of Social Cognition Deficits in Adolescents (Age 13-17) With Autism Spectrum Disorder and Effects of Gabapentin
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ClinicalTrials.gov Identifier: NCT03589898 |
Recruitment Status :
Recruiting
First Posted : July 18, 2018
Last Update Posted : April 5, 2022
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder | Drug: Gabapentin | Early Phase 1 |
The investigators will complete a 1H-MRS study in 42 adolescents with ASD. Given the low burden on patients, it is assumed that 90% of those recruited to participate in baseline 1H-MRS (Aim 1) will also consent/assent to repeated 1H-MRS after gabapentin administration (Aim 2). Projections from the preliminary study were used to select a proposed number of subjects that would be both achievable in the time frame of study and adequate to evaluate the research hypotheses.
Psychiatric comorbidity will be assessed based on DSM-5 criteria by clinical interview and administration of the Kiddie-Schedule for Affective Disorders and Schizophrenia (Present and Lifetime version; K-SADS-PL).
T1- and T2-weighted high resolution structural imaging (T1- and T2-weighted (MPRAGE)) will be acquired. These structural MRI scans will be analyzed using FreeSurfer (Martinos Center for Biomedical Imaging, Charlestown, MA) and Statistical Parameter Mapping (SPM8-http://www.fil.ion.ucl.ac.uk/spm/software/spm8/) to determine white matter, gray matter and CSF contributions to the MRS voxel for partial volume correction. This data will be analyzed for variation with age, and used as a co-variate in the statistical analysis plan.
MRS data will be acquired from the Anterior Cingulate Cortex and Right anterior insula. Imaging sessions will be conducted at the Advanced MRI Center (AMRIC) at UMMS, which houses a 3.0 Tesla Philips Achieva MRI research scanner (Philips Healthcare, Best, Netherlands) and 32-channel phase-array receiver SENSE head coil. AMRIC is dedicated to research and the MRI system has considerable evening and weekend availability. A Board certified neuroradiologist associated with the AMRIC at UMMS reviews all MRI scans. In the event of an unexpected, clinically important finding, the primary investigator will be informed. The investigator will share the finding with the participant and be in contact with the participant's primary care physician (PCP) in order to help decide the appropriate follow-up care/work up that is needed (consent will be obtained to contact each child's PCP during the study consent process).
GLU+GLN absolute levels will be quantified, and GABA levels will be quantified using the total creatine (tCr) peak as a reference. Macromolecule-suppressed editing will be used with MEGA-PRESS sequence, including prospective frequency correction to address the impact of drift and motion during scans.
Neurotransmitter levels will be correlated with social cognition measures. In females of reproductive age, menstrual cycle charting will be done for 2 months prior to scan, and imaging will be timed to target the mid-luteal phase, as cortical GABA levels fluctuate during the menstrual cycle and are most similar to levels in males during the luteal phase. In analysis of female subject data, menstrual phase will be confirmed on the day of the scan by measurement of serum estradiol and progesterone levels, and these levels will be used as covariates in the analysis. Exploratory analysis will be used to seek correlations with all clinical measures.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 42 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Imaging Biomarkers of Social Cognition and Pharmacologic Target Engagement in Autism Spectrum Disorder |
Actual Study Start Date : | September 14, 2017 |
Estimated Primary Completion Date : | August 31, 2022 |
Estimated Study Completion Date : | August 31, 2022 |

Arm | Intervention/treatment |
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Experimental: Gabapentin
Single dose of gabapentin 900 mg will be given and neuroimaging markers will be measured before and after administration of gabapentin
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Drug: Gabapentin
Single dose of gabapentin 900 mg |
- Cortical GABA in Anterior Cingulate Cortex [ Time Frame: 6 hours post-administration ]Cortical gamma-aminobutyric acid levels measured using magnetic resonance spectroscopy with voxel placed in bilateral anterior cingulate cortex
- Cortical GABA in Right Anterior Insula [ Time Frame: 6 hours post-administration ]Cortical gamma-aminobutyric acid levels measured using magnetic resonance spectroscopy with voxel placed in right anterior insula
- Cortical Glx in Anterior Cingulate Cortex [ Time Frame: 6 hours post-administration ]Cortical glutamate/glutamine levels measured using magnetic resonance spectroscopy with voxel placed in bilateral anterior cingulate cortex
- Cortical Glx in Right Anterior Insula [ Time Frame: 6 hours post-administration ]Cortical glutamate/glutamine levels measured using magnetic resonance spectroscopy with voxel placed in right anterior insula

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Ages Eligible for Study: | 13 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 13-17 years
- English as primary language (both child and legal guardian)
- DSM-5 criteria for Autism Spectrum Disorder
- IQ >70 per Weschler Abbreviated Scale of Intelligence (WASI)
- Informed assent for the study (The guardian must also give written informed consent).
Exclusion Criteria:
- Any neurological disorder (e.g., cerebral palsy, fetal alcohol syndrome, cerebral neoplasm, bacterial meningitis, epilepsy, etc.)
- Genetic disorders (e.g., Fragile X, Rett Syndrome, etc.)
- Preterm (<36 weeks)
- Failure to thrive within first year of life
- Contraindications for MRI, such as metallic or electronic implants in the body, or severe claustrophobia
- History of head trauma with loss of consciousness for more than 30 minutes
- Unstable psychiatric illness, history of psychotic disorder, or psychiatric illness that would prevent the subject from being able to complete study protocol
- Unstable medical illness such as diabetes, asthma, thyroid disease.
- Currently on medications that cause respiratory depression, e.g. opioids, benzodiazepines
- Clinically significant suicidal ideation at screening as assessed by the Columbia Suicide Severity Rating Scale
- IQ < 70
- History of intolerance to gabapentin or pregabalin
- Current substance use (including nicotine)
- Pregnancy at time of 1H-MRS or gabapentin administration
- Current treatment with gabapentin
- History of Renal Dysfunction
- Subjects who weigh less than 36 kg
- Subjects who weigh more than 105.8 kg

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): NCT03589898
Contact: David Cochran, MD, PhD | 508-856-5096 | david.cochran@umassmemorial.org | |
Contact: Arline Mata, BA | 774-455-4103 | Arline.Mata@umassmed.edu |
United States, Massachusetts | |
University of Massachusetts Medical School | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Arline Mata, BA 774-455-4112 arline.mata@umassmed.edu | |
Contact: Lauren Venuti, MSW 774-455-4103 Childresearch@umassmed.edu |
Principal Investigator: | David Cochran, MD, PhD | University of Massachusetts, Worcester |
Responsible Party: | David Cochran, Assistant Professor of Psychiatry and Pediatrics, University of Massachusetts, Worcester |
ClinicalTrials.gov Identifier: | NCT03589898 |
Other Study ID Numbers: |
H00012656 1K23MH113008-01A1 ( U.S. NIH Grant/Contract ) |
First Posted: | July 18, 2018 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Plan for sharing individual participant data is still being discussed and developed by study team. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
magnetic resonance imaging spectroscopy GABA glutamate social cognition |
Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents |