Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics (IMPACT)
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ClinicalTrials.gov Identifier: NCT00806234 |
Recruitment Status
:
Completed
First Posted
: December 10, 2008
Results First Posted
: April 25, 2017
Last Update Posted
: April 25, 2017
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | December 9, 2008 | ||||||||||||
First Posted Date ICMJE | December 10, 2008 | ||||||||||||
Results First Submitted Date | July 2, 2016 | ||||||||||||
Results First Posted Date | April 25, 2017 | ||||||||||||
Last Update Posted Date | April 25, 2017 | ||||||||||||
Study Start Date ICMJE | January 2009 | ||||||||||||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Body Mass Index (BMI) Z-score Change [ Time Frame: Change from baseline to 24 weeks ] | ||||||||||||
Original Primary Outcome Measures ICMJE |
Body Mass Index (BMI) Z-score Change [ Time Frame: Measured at Week 24 ] | ||||||||||||
Change History | Complete list of historical versions of study NCT00806234 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title ICMJE | Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics | ||||||||||||
Official Title ICMJE | Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) | ||||||||||||
Brief Summary | This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications. | ||||||||||||
Detailed Description | Disorders that involve severe dysregulation of mood or thoughts in children -- such as early onset bipolar spectrum (BPS) and schizophrenia spectrum (SS) disorders -- are commonly treated with antipsychotic medications. However, many of the newest and most commonly prescribed antipsychotic medications can cause weight gain and metabolic dysfunctions. Use of these newer antipsychotics, called second generation antipsychotics (SGAs), is increasing rapidly in children, and the risk of weight gain from SGAs is higher among children than adults. Excessive weight gain can lead to obesity, which, in turn, can lead to increased health care costs, increased risk of sickness, and lower life expectancy. These factors are enhanced in children and adolescents who grow up obese. Two different strategies to reduce weight gain and metabolic side effects from SGAs will be tested in this study. The first strategy involves switching from the current SGA to a lower risk agent (aripiprazole or perphenazine) hypothesized to result in weight loss and improved metabolic functioning. The second strategy involves taking the medication metformin in addition to the current SGA. Metformin is approved by the Food and Drug Administration (FDA) to promote weight loss in youth with diabetes and has been effective in reducing weight in youth taking SGAs. Participation in this study will last between 26 and 27 weeks and will be divided into two parts. The first part will last 2 to 3 weeks and include three study visits. During this part, participants will undergo a physical exam, an electrocardiogram (EKG), a dual energy X-ray absorptiometry (DXA) test, and blood tests. The DXA measures body fat. The second part will last 24 weeks and include nine study visits. During this part, participants will be randomly assigned to one of three conditions: gradual switch of current SGA medication to either aripiprazole or perphenazine, addition of metformin to current SGA medication, or no change to treatment with current SGA medication. Visits will take place on Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24. At each visit, participants will meet with a study doctor who will assess symptoms and side effects, and participants and their guardians will receive information and recommendations about childhood obesity and weight loss. There will also be monthly urine pregnancy tests, and two blood tests. |
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Study Type ICMJE | Interventional | ||||||||||||
Study Phase | Phase 4 | ||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Psychotic Disorders | ||||||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Reeves GM, Keeton C, Correll CU, Johnson JL, Hamer RM, Sikich L, Hazzard L, Alderman C, Scheer A, Mabe M, Kapoor S, Sheridan E, Borner I, Bussell K, Pirmohamed S, Bethea TC, Chekuri R, Gottfried R, Reinblatt SP, Santana E, Riddle MA. Improving metabolic parameters of antipsychotic child treatment (IMPACT) study: rationale, design, and methods. Child Adolesc Psychiatry Ment Health. 2013 Aug 15;7(1):31. doi: 10.1186/1753-2000-7-31. | ||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||
Actual Enrollment ICMJE |
127 | ||||||||||||
Original Estimated Enrollment ICMJE |
240 | ||||||||||||
Actual Study Completion Date | March 2014 | ||||||||||||
Actual Primary Completion Date | March 2014 (Final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 8 Years to 19 Years (Child, Adult) | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
Listed Location Countries ICMJE | United States | ||||||||||||
Removed Location Countries | |||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT00806234 | ||||||||||||
Other Study ID Numbers ICMJE | R01MH080270( U.S. NIH Grant/Contract ) R01MH080270 ( U.S. NIH Grant/Contract ) DSIR 84-CTS |
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Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||
IPD Sharing Statement | Not Provided | ||||||||||||
Responsible Party | Mark Riddle, MD, Johns Hopkins University | ||||||||||||
Study Sponsor ICMJE | Johns Hopkins University | ||||||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Johns Hopkins University | ||||||||||||
Verification Date | April 2017 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |