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| ID | Type | Description | Link |
|---|---|---|---|
| 5K12DA000357-17 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study proposes to use quetiapine as an adjunct treatment to treatment as usual to improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design study. Youth with symptoms of mood dysregulation and active substance use that meets criteria for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The investigators hypothesize that treatment with quetiapine will lead to a reduction in substance use, improvement in mood, and lead to greater engagement in outpatient treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine | Experimental | Quetiapine |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Timeline Followback of Substance Use (TLFB) | 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. | baseline, 8 weeks |
| Change in Symptoms of Mania | 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. | baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Negative Urine Toxicology Specimens | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Yule, M.D. | Boston Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Timeline Followback of Substance Use (TLFB) | 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. | 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. | Posted | Mean | Standard Deviation | Days | baseline, 8 weeks |
|
10 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amy Yule, MD | Boston Medical Center | 617-414-1936 | amy.yule@bmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2021 | Mar 15, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 22, 2021 | Mar 15, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D001714 | Bipolar Disorder |
| D019964 | Mood Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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|
| Placebo | Other | 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. |
|
| baseline, 8 weeks |
| Change in Craving for the Substance That the Participant Identifies as Most Problematic | 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. | baseline, 8 weeks |
| Change in Symptoms of Depression | 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. | baseline, 8 weeks |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Beck Depression Inventory-II (BDI-II) | The BDI-II assesses depressive symptomatology over the 2 weeks prior to administration. It is a 21-item scale with each question rated with a Likert rating scale from 0 to 3, and the total score representing a summation of all responses ranging from 0 to 63, with higher scores indicating greater impairment. | Data only available for participants who took at least one week of study medication. | Mean | Standard Deviation | Score on a scale |
|
| Young Mania Rating Scale | The YMRS is composed of 11 items, each rated with a Likert rating 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. | Data only available for participants who took at least one week of study medication. | Mean | Standard Deviation | Score on a scale |
|
| Weiss Craving Scale | The Weiss Craving Scale is a 3-item scale with each question rated with a Likert scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use), and the total score representing the summation of all responses ranging from 0 to 27, with higher scores indicating more severe cravings. | Data only available for participants who took at least one week of study medication. | Mean | Standard Deviation | Score on a scale |
|
| Number of Participants with a Negative Urine Screen at Baseline | 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. | 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. | Number | Participants |
|
| Timeline Followback of Substance Use (TLFB) | 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. | 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. | Mean | Standard Deviation | days |
|
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.
|
|
| Primary | Change in Symptoms of Mania | 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. | Participants who took at least one week of study medication and completed the YMRS at baseline and at least one follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Change in the Number of Negative Urine Toxicology Specimens | 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. | 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. | Posted | Median | Inter-Quartile Range | Proportion of Specimens | baseline, 8 weeks |
|
|
|
| Secondary | Change in Craving for the Substance That the Participant Identifies as Most Problematic | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| Secondary | Change in Symptoms of Depression | 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. | Participants who took at least one week of study medication and completed the BDI-II at baseline and at least one follow-up visit. | Posted | Mean | Standard Deviation | score on a scale | baseline, 8 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 11 |
| 11 |
| EG001 | 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. | 0 | 10 | 0 | 10 | 10 | 10 |
| Tootheache | Nervous system disorders | Systematic Assessment |
|
| Muscle Spasm | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Burn on Skin | General disorders | Systematic Assessment |
|
| Chest Pain | Vascular disorders | Systematic Assessment |
|
| Nausea/Vomitting | Gastrointestinal disorders | Systematic Assessment |
|
| Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Fatigue/Drowsiness/Sedation | General disorders | Systematic Assessment |
|
| Decreased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Upset Stomach/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomach Cramps | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | Systematic Assessment |
|
| Vaginal Yeast Infection | Infections and infestations | Systematic Assessment |
|
| Erectile Dysfunction | Reproductive system and breast disorders | Systematic Assessment |
|
| Visual Hallucination | Psychiatric disorders | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Increased Appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Increased General Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Increased Thirst and Dry Mouth | Metabolism and nutrition disorders | Systematic Assessment |
|
| HSV Outbreak on Tailbone | Infections and infestations | Systematic Assessment |
|
| Joint Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Sleep Paralysis | Psychiatric disorders | Systematic Assessment |
|
| Knee Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|