Trial Outcomes & Findings for Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders (NCT NCT01302964)

Last Updated: 2018-11-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

30 participants

Primary outcome timeframe

Weeks Baseline, 2, 4, 6, and 10

Results posted on

2018-11-07

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	20	10
Overall Study COMPLETED	19	10
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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
Overall Study Adverse Event	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirtazapine n=20 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 subjects weighing less than 50 kg and up to 15 mg weekly for subjects weighing more than 50 kg depending upon efficacy and tolerability.	Placebo n=10 Participants 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 n=30 Participants Total of all reporting groups
Age, Continuous	10.9 years STANDARD_DEVIATION 3.6 • n=5 Participants	11.3 years STANDARD_DEVIATION 4.1 • n=7 Participants	11.0 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	9 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	10 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks Baseline, 2, 4, 6, and 10

Population: All randomized study participants

Outcome measures

Outcome measures
Measure	Mirtazapine n=20 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.	Placebo n=10 Participants 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
Mean 10-Week Change in Pediatric Anxiety Rating Scale 5-Item Total Score, Double-blind Phase	-4.9 score on a scale Interval -7.3 to -2.6	-3.2 score on a scale Interval -6.5 to 0.2

PRIMARY outcome

Timeframe: Screen (Visit 1) Baseline (Visit 2) and Endpoint (Week 10)

Population: All randomized study participants with a 10 week CGI-I rating

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.

Outcome measures

Outcome measures
Measure	Mirtazapine n=19 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.	Placebo n=10 Participants 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
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)	0.47 Proportion of participants	0.20 Proportion of participants

Adverse Events

Mirtazapine

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Christopher J. McDougle, MD

Massachusetts General Hospital

Phone: 781-860-1783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Mirtazapine n=20 participants at risk 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.	Placebo n=10 participants at risk 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
Eye disorders Eye Irritation	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Nausea	30.0% 6/20 • 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.	30.0% 3/10 • 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.
Gastrointestinal disorders Diarrhea	25.0% 5/20 • 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.	20.0% 2/10 • 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.
Gastrointestinal disorders Stomach or abdominal discomfort	25.0% 5/20 • 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.	40.0% 4/10 • 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.
Gastrointestinal disorders Vomiting	15.0% 3/20 • 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.	40.0% 4/10 • 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.
Gastrointestinal disorders Constipation	15.0% 3/20 • 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.	30.0% 3/10 • 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.
Gastrointestinal disorders Taste abnormality	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Gastrointestinal disorders Indigestion	0.00% 0/20 • 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.	10.0% 1/10 • 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.
General disorders Sedation/Drowsiness	60.0% 12/20 • 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.	60.0% 6/10 • 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.
General disorders Appetite increase	50.0% 10/20 • 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.	20.0% 2/10 • 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.
General disorders Appetite decrease	10.0% 2/20 • 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.	20.0% 2/10 • 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.
General disorders Fever	10.0% 2/20 • 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.	20.0% 2/10 • 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.
General disorders Dry mouth	10.0% 2/20 • 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.	0.00% 0/10 • 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.
General disorders Tiredness/fatigue	10.0% 2/20 • 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.	0.00% 0/10 • 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.
General disorders Accidental injury	5.0% 1/20 • 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.	0.00% 0/10 • 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.
General disorders Other Pain	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Immune system disorders Allergies Not Otherwise Specified	5.0% 1/20 • 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.	10.0% 1/10 • 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.
Infections and infestations Nasal congestion or Cold	20.0% 4/20 • 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.	20.0% 2/10 • 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.
Infections and infestations Unspecified or not otherwise listed nose/throat	10.0% 2/20 • 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.	10.0% 1/10 • 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.
Infections and infestations Sinus condition	10.0% 2/20 • 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.	0.00% 0/10 • 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.
Infections and infestations Flu or upper respiratory problems	0.00% 0/20 • 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.	20.0% 2/10 • 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.
Infections and infestations Ear Infection	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Infections and infestations Sore throat	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Infections and infestations Throat infection	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Infections and infestations Unspecified or not otherwise listed mouth	0.00% 0/20 • 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.	10.0% 1/10 • 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.
Musculoskeletal and connective tissue disorders Unspecified or not otherwise listed, musculoskeletal	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Nervous system disorders Headache	15.0% 3/20 • 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.	20.0% 2/10 • 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.
Nervous system disorders Sensory sensitivity	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Aggression	25.0% 5/20 • 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.	40.0% 4/10 • 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.
Psychiatric disorders Nightmares or Dreams	20.0% 4/20 • 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.	20.0% 2/10 • 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.
Psychiatric disorders Irritability	35.0% 7/20 • 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.	30.0% 3/10 • 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.
Psychiatric disorders Sadness	20.0% 4/20 • 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.	30.0% 3/10 • 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.
Psychiatric disorders Difficulty falling asleep	15.0% 3/20 • 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.	10.0% 1/10 • 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.
Psychiatric disorders Interrupted sleep/other sleep problems	10.0% 2/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Concentration difficulty	10.0% 2/20 • 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.	10.0% 1/10 • 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.
Psychiatric disorders Anxiety/Nervousness/Worry	10.0% 2/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Body-focused repetitive behavior	10.0% 2/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Change in speech	10.0% 2/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Euphoria/Giddiness	5.0% 1/20 • 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.	0.00% 0/10 • 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.
Psychiatric disorders Increased motor activity	5.0% 1/20 • 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.	0.00% 0/10 • 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.