Trial · NCT01302964

Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

NCT01302964, Phase 3, Completed, Massachusetts General Hospital; results first posted 2018-11-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders. Trials, record NCT01302964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01302964

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders
NCT number: NCT01302964
Status: Completed
Phases: Phase 3
Enrollment: 30 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Autism Spectrum Disorders
Interventions: Placebo, Mirtazapine
First posted: 2011-02-24
Last updated: 2018-11-07
Results first posted: 2018-11-07

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase	Weeks Baseline, 2, 4, 6, and 10	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.
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)	Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase	Weeks Baseline, 2, 4, 6, and 10	All randomized study participants	score on a scale	MEAN
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)	Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)	All randomized study participants with a 10 week CGI-I rating	Proportion of participants	NUMBER

Source ClinicalTrials.gov

Results by group4

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase	Mirtazapine	-4.9	95% Confidence Interval -7.3 to -2.6	score on a scale
Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase	Placebo	-3.2	95% Confidence Interval -6.5 to 0.2	score on a scale
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)	Mirtazapine	0.47		Proportion of participants
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)	Placebo	0.20		Proportion of participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Mirtazapine	20
Overall Study	STARTED	Placebo	10
Overall Study	COMPLETED	Mirtazapine	19
Overall Study	COMPLETED	Placebo	10
Overall Study	NOT COMPLETED	Mirtazapine	1
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events112

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Eye Irritation	Eye disorders	Mirtazapine	1	20
other	Eye Irritation	Eye disorders	Placebo	0	10
other	Nausea	Gastrointestinal disorders	Mirtazapine	6	20
other	Nausea	Gastrointestinal disorders	Placebo	3	10
other	Diarrhea	Gastrointestinal disorders	Mirtazapine	5	20
other	Diarrhea	Gastrointestinal disorders	Placebo	2	10
other	Stomach or abdominal discomfort	Gastrointestinal disorders	Mirtazapine	5	20
other	Stomach or abdominal discomfort	Gastrointestinal disorders	Placebo	4	10
other	Vomiting	Gastrointestinal disorders	Mirtazapine	3	20
other	Vomiting	Gastrointestinal disorders	Placebo	4	10

1 to 10 of 112Source ClinicalTrials.gov

See all 112 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Mirtazapine	0	20
Total, all-cause mortality	Placebo	0	10
Total, other adverse events	Mirtazapine	20	20
Total, other adverse events	Placebo	10	10
Total, serious adverse events	Mirtazapine	0	20
Total, serious adverse events	Placebo	0	10

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35241779	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Mirtazapine vs Placebo: deaths from any cause	Trial comparisons
Mirtazapine vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01302964

GET https://conductscience.org/api/trials/v1/NCT01302964/events?page=2

API reference For AI assistants