Trial Outcomes & Findings for Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation (NCT NCT02845453)
NCT ID: NCT02845453
Last Updated: 2022-05-11
Results Overview
The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
baseline, 8 weeks
Results posted on
2022-05-11
Participant Flow
Participant milestones
| Measure |
Quetiapine
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
Took One Dose of Study Medication
|
11
|
10
|
|
Overall Study
Took One Week of Study Medication
|
10
|
9
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Data only available for participants who took at least one week of study medication.
Baseline characteristics by cohort
| Measure |
Quetiapine
n=13 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=11 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=13 Participants
|
11 Participants
n=11 Participants
|
23 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Age, Continuous
|
21.2 years
STANDARD_DEVIATION 2.1 • n=13 Participants
|
20.5 years
STANDARD_DEVIATION 1.8 • n=11 Participants
|
20.8 years
STANDARD_DEVIATION 1.9 • n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=13 Participants
|
7 Participants
n=11 Participants
|
15 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=13 Participants
|
4 Participants
n=11 Participants
|
9 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=13 Participants
|
1 Participants
n=11 Participants
|
4 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=13 Participants
|
10 Participants
n=11 Participants
|
20 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=13 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=13 Participants
|
2 Participants
n=11 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=13 Participants
|
6 Participants
n=11 Participants
|
15 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=13 Participants
|
1 Participants
n=11 Participants
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
11 participants
n=11 Participants
|
24 participants
n=24 Participants
|
|
Beck Depression Inventory-II (BDI-II)
|
25 Score on a scale
STANDARD_DEVIATION 9.5 • n=10 Participants • Data only available for participants who took at least one week of study medication.
|
25.9 Score on a scale
STANDARD_DEVIATION 9 • n=9 Participants • Data only available for participants who took at least one week of study medication.
|
25.4 Score on a scale
STANDARD_DEVIATION 9 • n=19 Participants • Data only available for participants who took at least one week of study medication.
|
|
Young Mania Rating Scale
|
18.8 Score on a scale
STANDARD_DEVIATION 4.9 • n=10 Participants • Data only available for participants who took at least one week of study medication.
|
14.6 Score on a scale
STANDARD_DEVIATION 5.4 • n=9 Participants • Data only available for participants who took at least one week of study medication.
|
16.9 Score on a scale
STANDARD_DEVIATION 5.4 • n=19 Participants • Data only available for participants who took at least one week of study medication.
|
|
Weiss Craving Scale
|
17.1 Score on a scale
STANDARD_DEVIATION 5.7 • n=10 Participants • Data only available for participants who took at least one week of study medication.
|
16.4 Score on a scale
STANDARD_DEVIATION 6.3 • n=9 Participants • Data only available for participants who took at least one week of study medication.
|
16.8 Score on a scale
STANDARD_DEVIATION 5.8 • n=19 Participants • Data only available for participants who took at least one week of study medication.
|
|
Number of Participants with a Negative Urine Screen at Baseline
|
1 Participants
n=8 Participants • Data only available for participants who took at least one week of study medication, completed at least one post-baseline urine toxicology screen, and whose drug of choice could be assessed with urine toxicology testing.
|
2 Participants
n=7 Participants • Data only available for participants who took at least one week of study medication, completed at least one post-baseline urine toxicology screen, and whose drug of choice could be assessed with urine toxicology testing.
|
3 Participants
n=15 Participants • Data only available for participants who took at least one week of study medication, completed at least one post-baseline urine toxicology screen, and whose drug of choice could be assessed with urine toxicology testing.
|
|
Timeline Followback of Substance Use (TLFB)
|
19.5 days
STANDARD_DEVIATION 9.3 • n=8 Participants • Data only available for participants who took at least one week of study medication, and 28 days of information on timeline follow back for substance use after starting study medication.
|
15.4 days
STANDARD_DEVIATION 8.2 • n=8 Participants • Data only available for participants who took at least one week of study medication, and 28 days of information on timeline follow back for substance use after starting study medication.
|
17.4 days
STANDARD_DEVIATION 8.8 • n=16 Participants • Data only available for participants who took at least one week of study medication, and 28 days of information on timeline follow back for substance use after starting study medication.
|
PRIMARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants who completed at least one week of study medication and had 28 days-worth of past substance use data at baseline and study endpoint.
The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days.
Outcome measures
| Measure |
Quetiapine
n=8 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=8 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Change in Timeline Followback of Substance Use (TLFB)
|
2.3 Days
Standard Deviation 6.9
|
3.3 Days
Standard Deviation 6
|
PRIMARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants who took at least one week of study medication and completed the YMRS at baseline and at least one follow-up visit.
Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale. Each item is composed of 5 explicitly defined levels of severity. Severity ratings for 7 items are scored on a scale of 0 -4. The remaining 4 items are double weighted to account for poor cooperation of client when unwell and are scored on a scale of 0 - 8. Item ratings are sum to produce a total YMRS score between 0 -60. Higher scores on the YMRS indicate greater symptoms of mania.
Outcome measures
| Measure |
Quetiapine
n=10 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=8 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Change in Symptoms of Mania
|
-8.8 score on a scale
Standard Deviation 8.1
|
-0.4 score on a scale
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants who took at least one week of study medication, completed at least one post-baseline urine toxicology screen, and whose drug of choice could be assessed with urine toxicology testing.
Urine toxicology specimens for the participant's drug of choice assessed as positive or negative. For each participant, the proportion of urine toxicology specimens that are negative over the course of the trial are calculated as the number of negative specimens divided by the total number of specimens collected from week 1 until study endpoint.
Outcome measures
| Measure |
Quetiapine
n=8 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=8 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Change in the Number of Negative Urine Toxicology Specimens
|
0 Proportion of Specimens
Interval 0.0 to 0.14
|
0 Proportion of Specimens
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants who took at least one week of study medication and completed the Weiss Craving Scale at baseline and at least one follow-up visit.
Craving will be measured by the Weiss Craving Scale. This scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use). The total Weiss Craving Scale score ranges from 0 to 27. Higher scores on the Weiss Craving Scale indicate greater cravings for a substance.
Outcome measures
| Measure |
Quetiapine
n=10 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=9 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Change in Craving for the Substance That the Participant Identifies as Most Problematic
|
-1.8 score on a scale
Standard Deviation 4.5
|
0.4 score on a scale
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: Participants who took at least one week of study medication and completed the BDI-II at baseline and at least one follow-up visit.
Symptoms of depression will be assessed using the Beck Depression Inventory II (BDI-II) scale. The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe). Total scores on the BDI-II range from 0 to 63. Higher scores indicate greater symptoms of depression.
Outcome measures
| Measure |
Quetiapine
n=10 Participants
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=9 Participants
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Change in Symptoms of Depression
|
-9.1 score on a scale
Standard Deviation 13.5
|
-6.2 score on a scale
Standard Deviation 10.6
|
Adverse Events
Quetiapine
Serious events: 0 serious events
Other events: 11 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
| Measure |
Quetiapine
n=11 participants at risk
Quetiapine
Quetiapine: Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
Placebo
n=10 participants at risk
Placebo
Placebo: Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Abdominal Pain
|
9.1%
1/11 • Number of events 2 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Nervous system disorders
Tootheache
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasm
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle Pain
|
18.2%
2/11 • Number of events 4 • 10 weeks
|
30.0%
3/10 • Number of events 3 • 10 weeks
|
|
General disorders
Burn on Skin
|
0.00%
0/11 • 10 weeks
|
10.0%
1/10 • Number of events 2 • 10 weeks
|
|
Vascular disorders
Chest Pain
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Gastrointestinal disorders
Nausea/Vomitting
|
27.3%
3/11 • Number of events 8 • 10 weeks
|
40.0%
4/10 • Number of events 5 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
18.2%
2/11 • Number of events 4 • 10 weeks
|
50.0%
5/10 • Number of events 6 • 10 weeks
|
|
General disorders
Fatigue/Drowsiness/Sedation
|
90.9%
10/11 • Number of events 24 • 10 weeks
|
40.0%
4/10 • Number of events 7 • 10 weeks
|
|
Gastrointestinal disorders
Decreased Appetite
|
18.2%
2/11 • Number of events 4 • 10 weeks
|
10.0%
1/10 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Upset Stomach/Diarrhea
|
18.2%
2/11 • Number of events 2 • 10 weeks
|
20.0%
2/10 • Number of events 3 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
18.2%
2/11 • Number of events 2 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Gastrointestinal disorders
Stomach Cramps
|
9.1%
1/11 • Number of events 3 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
General disorders
Dizziness
|
9.1%
1/11 • Number of events 2 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Renal and urinary disorders
Dysuria
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Infections and infestations
Vaginal Yeast Infection
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Psychiatric disorders
Visual Hallucination
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Nervous system disorders
Paresthesia
|
18.2%
2/11 • Number of events 2 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Nervous system disorders
Headache
|
27.3%
3/11 • Number of events 5 • 10 weeks
|
50.0%
5/10 • Number of events 17 • 10 weeks
|
|
Gastrointestinal disorders
Heartburn
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
10.0%
1/10 • Number of events 1 • 10 weeks
|
|
Gastrointestinal disorders
Increased Appetite
|
18.2%
2/11 • Number of events 2 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Psychiatric disorders
Increased General Anxiety
|
0.00%
0/11 • 10 weeks
|
10.0%
1/10 • Number of events 3 • 10 weeks
|
|
Metabolism and nutrition disorders
Increased Thirst and Dry Mouth
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Infections and infestations
HSV Outbreak on Tailbone
|
0.00%
0/11 • 10 weeks
|
10.0%
1/10 • Number of events 1 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
9.1%
1/11 • Number of events 3 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Psychiatric disorders
Sleep Paralysis
|
9.1%
1/11 • Number of events 1 • 10 weeks
|
0.00%
0/10 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Knee Pain
|
0.00%
0/11 • 10 weeks
|
10.0%
1/10 • Number of events 1 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • 10 weeks
|
10.0%
1/10 • Number of events 1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place