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Trial record 4 of 53 for:    Developmental Disabilities | ( Map: Indiana, United States )

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

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ClinicalTrials.gov Identifier: NCT01302964
Recruitment Status : Completed
First Posted : February 24, 2011
Results First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Collaborator:
Autism Speaks
Information provided by (Responsible Party):
Christopher John McDougle, M.D., Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Autism Spectrum Disorders
Interventions Drug: Placebo
Drug: Mirtazapine
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Mirtazapine Placebo
Hide Arm/Group Description

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.

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

Period Title: Overall Study
Started 20 10
Completed 19 10
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title Mirtazapine Placebo Total
Hide Arm/Group Description

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.

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

Total of all reporting groups
Overall Number of Baseline Participants 20 10 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 10 participants 30 participants
10.9  (3.6) 11.3  (4.1) 11.0  (3.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Female
3
  15.0%
3
  30.0%
6
  20.0%
Male
17
  85.0%
7
  70.0%
24
  80.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
Hispanic or Latino
2
  10.0%
2
  20.0%
4
  13.3%
Not Hispanic or Latino
16
  80.0%
8
  80.0%
24
  80.0%
Unknown or Not Reported
2
  10.0%
0
   0.0%
2
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 10 participants 30 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.0%
0
   0.0%
1
   3.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   5.0%
1
  10.0%
2
   6.7%
White
17
  85.0%
9
  90.0%
26
  86.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   5.0%
0
   0.0%
1
   3.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 10 participants 30 participants
20 10 30
1.Primary Outcome
Title Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase
Hide Description 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.
Time Frame Weeks Baseline, 2, 4, 6, and 10
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants
Arm/Group Title Mirtazapine Placebo
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 20 10
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-4.9
(-7.3 to -2.6)
-3.2
(-6.5 to 0.2)
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized study participants with a 10 week CGI-I rating
Arm/Group Title Mirtazapine Placebo
Hide Arm/Group Description:

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.

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

Overall Number of Participants Analyzed 19 10
Measure Type: Number
Unit of Measure: Proportion of participants
0.47 0.20
Time Frame Ten weeks or at the time of latest data collection for the participant who did not complete the study.
Adverse Event Reporting Description 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.
 
Arm/Group Title Mirtazapine Placebo
Hide Arm/Group Description

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.

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

All-Cause Mortality
Mirtazapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/10 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Mirtazapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Mirtazapine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   20/20 (100.00%)   10/10 (100.00%) 
Eye disorders     
Eye Irritation   1/20 (5.00%)  0/10 (0.00%) 
Gastrointestinal disorders     
Nausea   6/20 (30.00%)  3/10 (30.00%) 
Diarrhea   5/20 (25.00%)  2/10 (20.00%) 
Stomach or abdominal discomfort   5/20 (25.00%)  4/10 (40.00%) 
Vomiting   3/20 (15.00%)  4/10 (40.00%) 
Constipation   3/20 (15.00%)  3/10 (30.00%) 
Taste abnormality   1/20 (5.00%)  0/10 (0.00%) 
Indigestion   0/20 (0.00%)  1/10 (10.00%) 
General disorders     
Sedation/Drowsiness   12/20 (60.00%)  6/10 (60.00%) 
Appetite increase   10/20 (50.00%)  2/10 (20.00%) 
Appetite decrease   2/20 (10.00%)  2/10 (20.00%) 
Fever   2/20 (10.00%)  2/10 (20.00%) 
Dry mouth   2/20 (10.00%)  0/10 (0.00%) 
Tiredness/fatigue   2/20 (10.00%)  0/10 (0.00%) 
Accidental injury   1/20 (5.00%)  0/10 (0.00%) 
Other Pain   1/20 (5.00%)  0/10 (0.00%) 
Immune system disorders     
Allergies Not Otherwise Specified   1/20 (5.00%)  1/10 (10.00%) 
Infections and infestations     
Nasal congestion or Cold   4/20 (20.00%)  2/10 (20.00%) 
Unspecified or not otherwise listed nose/throat   2/20 (10.00%)  1/10 (10.00%) 
Sinus condition   2/20 (10.00%)  0/10 (0.00%) 
Flu or upper respiratory problems   0/20 (0.00%)  2/10 (20.00%) 
Ear Infection   1/20 (5.00%)  0/10 (0.00%) 
Sore throat   1/20 (5.00%)  0/10 (0.00%) 
Throat infection   1/20 (5.00%)  0/10 (0.00%) 
Unspecified or not otherwise listed mouth   0/20 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Unspecified or not otherwise listed, musculoskeletal   1/20 (5.00%)  0/10 (0.00%) 
Nervous system disorders     
Headache   3/20 (15.00%)  2/10 (20.00%) 
Sensory sensitivity   1/20 (5.00%)  0/10 (0.00%) 
Psychiatric disorders     
Aggression  [1]  5/20 (25.00%)  4/10 (40.00%) 
Nightmares or Dreams   4/20 (20.00%)  2/10 (20.00%) 
Irritability   7/20 (35.00%)  3/10 (30.00%) 
Sadness   4/20 (20.00%)  3/10 (30.00%) 
Difficulty falling asleep   3/20 (15.00%)  1/10 (10.00%) 
Interrupted sleep/other sleep problems   2/20 (10.00%)  0/10 (0.00%) 
Concentration difficulty   2/20 (10.00%)  1/10 (10.00%) 
Anxiety/Nervousness/Worry   2/20 (10.00%)  0/10 (0.00%) 
Body-focused repetitive behavior   2/20 (10.00%)  0/10 (0.00%) 
Change in speech   2/20 (10.00%)  0/10 (0.00%) 
Euphoria/Giddiness   1/20 (5.00%)  0/10 (0.00%) 
Increased motor activity   1/20 (5.00%)  0/10 (0.00%) 
Restlessness/Agitation including fidgety   1/20 (5.00%)  1/10 (10.00%) 
Unspecified or not otherwise listed psych   1/20 (5.00%)  0/10 (0.00%) 
Decreased motor activity   1/20 (5.00%)  0/10 (0.00%) 
Suicidal ideas   1/20 (5.00%)  0/10 (0.00%) 
Social withdrawal   2/20 (10.00%)  2/10 (20.00%) 
Stereotypy   1/20 (5.00%)  1/10 (10.00%) 
Compulsions   1/20 (5.00%)  0/10 (0.00%) 
Disinhibition   1/20 (5.00%)  0/10 (0.00%) 
Emotional outburst   1/20 (5.00%)  0/10 (0.00%) 
Self-injurious behavior   2/20 (10.00%)  0/10 (0.00%) 
Renal and urinary disorders     
Enuresis   3/20 (15.00%)  1/10 (10.00%) 
Skin and subcutaneous tissue disorders     
Localized rash   2/20 (10.00%)  1/10 (10.00%) 
Hair problems   1/20 (5.00%)  0/10 (0.00%) 
Sweating   1/20 (5.00%)  0/10 (0.00%) 
Vascular disorders     
Dizziness/faintness   2/20 (10.00%)  1/10 (10.00%) 
Intermittent nosebleed   1/20 (5.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Aggression (e.g. verbal threats to harm others, physical aggressions, not including disobedience or defiant/oppositional behavior)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Christopher J. McDougle, MD
Organization: Massachusetts General Hospital
Phone: 781-860-1783
Responsible Party: Christopher John McDougle, M.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01302964     History of Changes
Other Study ID Numbers: 2012P001009
First Submitted: August 25, 2010
First Posted: February 24, 2011
Results First Submitted: October 10, 2018
Results First Posted: November 7, 2018
Last Update Posted: November 7, 2018