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| Name | Class |
|---|---|
| Autism Speaks | OTHER |
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This study will determine the effectiveness of mirtazapine in reducing anxiety in children with autistic disorder, Asperger's disorder and Pervasive Developmental Disorder.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirtazapine | Experimental | The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg. |
|
| Placebo | Placebo Comparator | Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain inactive ingredients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Subjects randomized to placebo will receive placebo for duration of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase | 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. | Weeks Baseline, 2, 4, 6, and 10 |
| 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) | 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. | Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher J. McDougle, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Child and Adolescent Psychiatry Clinic Riley Hospital | Indianapolis | Indiana | 46202 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35241779 | Derived | McDougle CJ, Thom RP, Ravichandran CT, Palumbo ML, Politte LC, Mullett JE, Keary CJ, Erickson CA, Stigler KA, Mathieu-Frasier L, Posey DJ. A randomized double-blind, placebo-controlled pilot trial of mirtazapine for anxiety in children and adolescents with autism spectrum disorder. Neuropsychopharmacology. 2022 May;47(6):1263-1270. doi: 10.1038/s41386-022-01295-4. Epub 2022 Mar 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mirtazapine | The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg. 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 subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability. |
| FG001 | 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. Placebo: Subjects randomized to placebo will receive placebo for duration of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mirtazapine | The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg. 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 subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase | 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. | All randomized study participants | Posted | Mean | 95% Confidence Interval | score on a scale | Weeks Baseline, 2, 4, 6, and 10 |
|
Ten weeks or at the time of latest data collection for the participant who did not complete the study.
Adverse event information was collected via a structured side effect rating scale completed with the participant and their primary caregiver. This included a list of side-effects that have been reported with mirtazapine at a rate greater than 1%. The physician also asked about any visits to the doctor, new medication use, or any other complaints. Events that were not present at baseline and occurred or worsened after the date of randomization are reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mirtazapine | The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg. 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 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye Irritation | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher J. McDougle, MD | Massachusetts General Hospital | 781-860-1783 | cmcdougle@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2018 | Oct 4, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Mirtazapine | Drug | 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. |
|
|
| Lurie Center -MassGeneral Hospital |
| Lexington |
| Massachusetts |
| 02421 |
| United States |
| BG001 |
| 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. Placebo: Subjects randomized to placebo will receive placebo for duration of the study |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The starting dose for subjects is 7.5 mg daily. The maximum daily dose will be 45 mg.
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 50kg and up to 15 mg weekly for subjects weighing more than 50kg depending upon efficacy and tolerability.
| OG001 | 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. Placebo: Subjects randomized to placebo will receive placebo for duration of the study |
|
|
| Primary | 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) | 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. | All randomized study participants with a 10 week CGI-I rating | Posted | Number | Proportion of participants | Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10) |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 20 |
| 20 |
| EG001 | 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. Placebo: Subjects randomized to placebo will receive placebo for duration of the study | 0 | 10 | 0 | 10 | 10 | 10 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Stomach or abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Taste abnormality | Gastrointestinal disorders | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| Sedation/Drowsiness | General disorders | Systematic Assessment |
|
| Appetite increase | General disorders | Systematic Assessment |
|
| Appetite decrease | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Dry mouth | General disorders | Systematic Assessment |
|
| Tiredness/fatigue | General disorders | Systematic Assessment |
|
| Accidental injury | General disorders | Systematic Assessment |
|
| Other Pain | General disorders | Systematic Assessment |
|
| Allergies Not Otherwise Specified | Immune system disorders | Systematic Assessment |
|
| Nasal congestion or Cold | Infections and infestations | Systematic Assessment |
|
| Unspecified or not otherwise listed nose/throat | Infections and infestations | Systematic Assessment |
|
| Sinus condition | Infections and infestations | Systematic Assessment |
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| Flu or upper respiratory problems | Infections and infestations | Systematic Assessment |
|
| Ear Infection | Infections and infestations | Systematic Assessment |
|
| Sore throat | Infections and infestations | Systematic Assessment |
|
| Throat infection | Infections and infestations | Systematic Assessment |
|
| Unspecified or not otherwise listed mouth | Infections and infestations | Systematic Assessment |
|
| Unspecified or not otherwise listed, musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Sensory sensitivity | Nervous system disorders | Systematic Assessment |
|
| Aggression | Psychiatric disorders | Systematic Assessment | Aggression (e.g. verbal threats to harm others, physical aggressions, not including disobedience or defiant/oppositional behavior) |
|
| Nightmares or Dreams | Psychiatric disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Sadness | Psychiatric disorders | Systematic Assessment |
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| Difficulty falling asleep | Psychiatric disorders | Systematic Assessment |
|
| Interrupted sleep/other sleep problems | Psychiatric disorders | Systematic Assessment |
|
| Concentration difficulty | Psychiatric disorders | Systematic Assessment |
|
| Anxiety/Nervousness/Worry | Psychiatric disorders | Systematic Assessment |
|
| Body-focused repetitive behavior | Psychiatric disorders | Systematic Assessment |
|
| Change in speech | Psychiatric disorders | Systematic Assessment |
|
| Euphoria/Giddiness | Psychiatric disorders | Systematic Assessment |
|
| Increased motor activity | Psychiatric disorders | Systematic Assessment |
|
| Restlessness/Agitation including fidgety | Psychiatric disorders | Systematic Assessment |
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| Unspecified or not otherwise listed psych | Psychiatric disorders | Systematic Assessment |
|
| Decreased motor activity | Psychiatric disorders | Systematic Assessment |
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| Suicidal ideas | Psychiatric disorders | Systematic Assessment |
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| Social withdrawal | Psychiatric disorders | Systematic Assessment |
|
| Stereotypy | Psychiatric disorders | Systematic Assessment |
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| Enuresis | Renal and urinary disorders | Systematic Assessment |
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| Localized rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hair problems | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sweating | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Dizziness/faintness | Vascular disorders | Systematic Assessment |
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| Intermittent nosebleed | Vascular disorders | Systematic Assessment |
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| Compulsions | Psychiatric disorders | Systematic Assessment |
|
| Disinhibition | Psychiatric disorders | Systematic Assessment |
|
| Emotional outburst | Psychiatric disorders | Systematic Assessment |
|
| Self-injurious behavior | Psychiatric disorders | Systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |