Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02845453|
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Substance Use Disorders Bipolar Disorder Mood Disorders||Drug: Quetiapine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation|
|Actual Study Start Date :||January 20, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
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 Comparator: 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.
- Timeline Followback in Self-Reported Substance Use for Primary Substance of Use [ Time Frame: 8 weeks ]The timeline followback of substance use will be used to quantify self-reported alcohol and drug use.
- Mean Change in Young Mania Rating Scale (YMRS) Score [ Time Frame: 8 weeks ]The YMRS consists of 11 items rated on a scale from 0 (symptoms not present) to 4 (symptoms extremely severe). It is used to assess manic symptoms.
- Mean Change in Number of Toxicology Specimens Negative [ Time Frame: Baseline to 8 weeks ]The number of toxicology specimens for primary substance of use will be measured at baseline and endpoint.
- Mean Change in Weiss Craving Scale Score [ Time Frame: 8 weeks ]The Weiss Craving Scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use). It is used to assess cravings for a drug of choice.
- Mean Change in Beck Depression Inventory (BDI-II) Score [ Time Frame: 8 weeks ]The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe). It assesses depressive symptomatology over 2 weeks prior to administration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845453
|Contact: Rachael Lyons, BSfirstname.lastname@example.org|
|Contact: Elizabeth Noyes, BAemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Rachael Lyons, BS 617-724-5226 firstname.lastname@example.org|
|Contact: Elizabeth Noyes, BA 617-726-4651 email@example.com|
|Study Chair:||Amy Yule, M.D.||Massachusetts General Hospital|