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Terminated in lieu of similar,competing large, multi-site study.
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| Name | Class |
|---|---|
| Foundation of Hope, North Carolina | OTHER |
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The purpose of this study is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA):
The proposed pilot study is being conducted to obtain pilot data to support a grant application for a multi-site randomized controlled trial. The primary objective is to evaluate the relative risks and benefits of two approaches to the control of weight gain and other negative side effects in children and adolescents on 2nd generation antipsychotics (SGA). The critical question being addressed is: What can be done for the many youth who have gained substantial weight or developed high levels of lipids or glucose in their blood on an SGA; but due to their illness require continued treatment with an antipsychotic?
At least 40 youths (and no more than 60) age 10-17 that have gained substantial weight while taking a frequently used SGA: ziprasidone, aripiprazole or clozapine will be randomized to one of two treatments for 6 months:
Height, weight, body fat, and various blood tests indicative of general health will be collected during the 6 month trial to monitor the health benefits and safety of the interventions.
SGAs are associated with concerning degrees of weight gain and metabolic consequences. Children and adolescents, in whom SGAs are used increasingly for a wide variety of conditions, are particularly vulnerable to these side effects, which adversely affect health and longevity. It is imperative that researchers evaluate the efficacy and safety of interventions designed to prevent and treat the weight gain and metabolic problems caused by antipsychotic treatment of children. Lifestyle interventions and adjunctive medications all hold some promise of efficacy. However, it is essential that these strategies be rigorously evaluated as soon as possible in order to prevent the ongoing health consequences of SGA treatment in another generation of children with serious psychiatric illnesses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. |
|
| 2 | Experimental | Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors |
|
| 3 | No Intervention | Self-selected patients will be followed at major timepoints to assess weight and related measures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metformin | Drug | open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in BMI | 24 weeks | |
| Absolute Change in Weight | 24 weeks | |
| Percent Change in Fat Mass | 24 weeks | |
| Percent Change in Weight | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Insulin Levels | 24 weeks | |
| Percent Change in Total Cholesterol | 24 weeks | |
| Percent Change in Triglycerides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linmarie Sikich, MD | University of North Carolina, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Department of Psychiatry | Chapel Hill | North Carolina | 27599 | United States |
Randomization will be completed using computer generated randomization schedules. In order to preserve adequate sample sizes in the cells, important variables such as pubertal status, concomitant valproic acid, concomitant stimulants, gender, race (Asian/Caucasian vs. Other), and ethnicity (Hispanic/Non-Hispanic) will be examined as covariates.
Potential subjects will be identified through referrals that the research program receives for other clinical trials involving the same age population with similar diagnoses. We also plan to access PHI to identify potential subjects and use MIM and the ISD helpdesk to complete hospital review of individuals ages 10-17 taking an antipsychotic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Co-Treatment With Metformin | metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID |
| FG001 | Healthy Lifestyle Instruction Group | Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors. |
| FG002 | Elective Monitoring Control Group | For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Co-Treatment With Metformin | metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID |
| BG001 | Healthy Lifestyle Instruction Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Categorical | Number |
| 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 | Percent Change in BMI | This research study only enrolled a single study participant before the entire research study was terminated due to the start of a larger, multi-site trial evaluating similar outcome measures. | Posted | Number | percent change | 24 weeks |
|
Adverse event data were collected for the duration of the research study, which was a 6-month period.
The study only enrolled one patient who was diagnosed with Major Depressive Disorder. The subject completed all 24 weeks of study treatment and was randomly assigned to the co-treatment with metformin arm. The single study participant began treatment at dose of 1500mg for 1 week, and then maintained dose of 2000mg for remainder of study.
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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 | Co-Treatment With Metformin | metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted. metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID |
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In terms of study limitations, this research study was only able to enroll a single study participant before the trial was terminated prematurely due to study start-up for a larger, multisite effort examining similar outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linmarie Sikich, M.D. | The University of North Carolina at Chapel Hill | (919) 972-7499 | lsikich@med.unc.edu |
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| ID | Term |
|---|---|
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| healthy lifestyle intervention | Behavioral | additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors. |
|
| 24 weeks |
| Incidence of Metabolic Syndrome | 24 weeks |
| Percent Change in Glucose Levels | 24 weeks |
| Percent Change in HDL | 24 weeks |
| Percent Change in LDL | 24 weeks |
Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors. |
| BG002 | Elective Monitoring Control Group | For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention. |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Gender | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Elective Monitoring Control Group | For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention. |
|
|
| Primary | Absolute Change in Weight | Posted | Number | lbs. | 24 weeks |
|
|
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| Primary | Percent Change in Fat Mass | Posted | Number | percent change | 24 weeks |
|
|
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| Secondary | Percent Change in Insulin Levels | Posted | Number | percent change | 24 weeks |
|
|
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| Secondary | Percent Change in Total Cholesterol | Posted | Number | percent change | 24 weeks |
|
|
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| Secondary | Percent Change in Triglycerides | Posted | Number | percent change | 24 weeks |
|
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| Secondary | Incidence of Metabolic Syndrome | Posted | Number | participants | 24 weeks |
|
|
|
| Primary | Percent Change in Weight | Posted | Number | percent change | 24 weeks |
|
|
|
| Secondary | Percent Change in Glucose Levels | Posted | Number | percent change | 24 weeks |
|
|
|
| Secondary | Percent Change in HDL | Posted | Number | percent change | 24 weeks |
|
|
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| Secondary | Percent Change in LDL | Posted | Number | percent change | 24 weeks |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Healthy Lifestyle Instruction Group | Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors. | 0 | 0 | 0 | 0 |
| EG002 | Elective Monitoring Control Group | For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention. | 0 | 0 | 0 | 0 |
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