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Trial record 12 of 450 for:    QUETIAPINE

Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

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ClinicalTrials.gov Identifier: NCT02845453
Recruitment Status : Recruiting
First Posted : July 27, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Yule, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to determine whether quetiapine is effective in the treatment of youth with co-occurring substance use disorders and severe mood dysregulation.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Bipolar Disorder Mood Disorders Drug: Quetiapine Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Quetiapine
Quetiapine
Drug: 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 Comparator: Placebo
Placebo
Drug: 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 Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female age 15 to 24
  • Meet DSM-5 criteria for a substance use disorder
  • Substance use ≥ 14 days of past 28 days (i.e. use ≥ 50% of days in the past 28 days)
  • If subject in restricted setting/care (e.g. detox or residential treatment) for ≤ 2 weeks, then use ≥ 50% of days while outside of restricted setting (e.g. 7 days of substance use out of 14 days in unrestricted setting)
  • Subjects need to have been in an unrestricted setting for at least 2 weeks prior to screening
  • Meets DSM-5 criteria for bipolar disorder or disruptive mood dysregulation disorder or DSM IV criteria for mood disorder NOS
  • Symptoms of SMD: Youth Self Report (YSR) or Adult Self Report (ASR) AAA ≥180
  • Stable to be treated in outpatient level of care

Exclusion Criteria:

  • Current methamphetamine use disorder
  • Current unstable opioid use disorder (i.e. < 3 months on medication assisted treatment for an opioid use disorder)
  • Pregnant or breastfeeding
  • Placement in a restricted setting (e.g. detox or residential treatment) for ≥ 2 weeks out of past 28 days prior to screening visit, or placement in a restricted setting at anytime during study participation
  • Unwilling or unable to use effective birth control
  • Unwilling or unable to sign release of information for the treatment program providing behavioral treatment
  • For participants >17 years—unable or unwilling to identify emergency contact

Information from the National Library of Medicine

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


Contacts
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Contact: Rachael Lyons, BS 617-724-5226 rmlyons@mgh.harvard.edu
Contact: Elizabeth Noyes, BA 617-726-4651 enoyes@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Rachael Lyons, BS    617-724-5226    rmlyons@mgh.harvard.edu   
Contact: Elizabeth Noyes, BA    617-726-4651    enoyes@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Study Chair: Amy Yule, M.D. Massachusetts General Hospital

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Responsible Party: Amy Yule, Assistant in Psychiatry, Massachusetts General Hospital, Instructor at Harvard Medical School, Medical Director of the Addiction and Recovery Management Service, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02845453     History of Changes
Other Study ID Numbers: Quetiapine Protocol
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Amy Yule, Massachusetts General Hospital:
youth
adolescent
young adult
substance use disorder
bipolar disorder
quetiapine
mood dysregulation
Additional relevant MeSH terms:
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Quetiapine Fumarate
Disease
Substance-Related Disorders
Bipolar Disorder
Mood Disorders
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Chemically-Induced Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs