Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine (ZAC)
This study has been terminated.
(Terminated in lieu of similar,competing large, multi-site study.)
Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
Foundation of Hope, North Carolina
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00617058
First received: February 5, 2008
Last updated: November 28, 2012
Last verified: November 2012
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Results First Received: October 29, 2012
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
Weight Gain |
| Interventions: |
Drug: metformin Behavioral: healthy lifestyle intervention |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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. |
Pre-Assignment Details
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 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. |
Reporting Groups
| Description | |
|---|---|
| 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 |
| 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. |
| 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. |
Participant Flow: Overall Study
| Co-Treatment With Metformin | Healthy Lifestyle Instruction Group | Elective Monitoring Control Group | |
|---|---|---|---|
| STARTED | 1 | 0 | 0 |
| COMPLETED | 1 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| 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 |
| 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. |
| 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. |
| Total | Total of all reporting groups |
Baseline Measures
| Co-Treatment With Metformin | Healthy Lifestyle Instruction Group | Elective Monitoring Control Group | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
1 | 0 | 0 | 1 |
|
Age
[units: participants] |
||||
| <=18 years | 1 | 1 | ||
| Between 18 and 65 years | 0 | 0 | ||
| >=65 years | 0 | 0 | ||
|
Age
[units: years] Mean ± Standard Deviation |
17 | 17 | ||
|
Gender
[units: participants] |
||||
| Female | 0 | 0 | ||
| Male | 1 | 1 | ||
|
Region of Enrollment
[units: participants] |
||||
| United States | 1 | 1 |
Outcome Measures
| 1. Primary: | Percent Change in BMI [ Time Frame: 24 weeks ] |
| 2. Primary: | Absolute Change in Weight [ Time Frame: 24 weeks ] |
| 3. Primary: | Percent Change in Fat Mass [ Time Frame: 24 weeks ] |
| 4. Primary: | Percent Change in Weight [ Time Frame: 24 weeks ] |
| 5. Secondary: | Percent Change in Insulin Levels [ Time Frame: 24 weeks ] |
| 6. Secondary: | Percent Change in Total Cholesterol [ Time Frame: 24 weeks ] |
| 7. Secondary: | Percent Change in Triglycerides [ Time Frame: 24 weeks ] |
| 8. Secondary: | Incidence of Metabolic Syndrome [ Time Frame: 24 weeks ] |
| 9. Secondary: | Percent Change in Glucose Levels [ Time Frame: 24 weeks ] |
| 10. Secondary: | Percent Change in HDL [ Time Frame: 24 weeks ] |
| 11. Secondary: | Percent Change in LDL [ Time Frame: 24 weeks ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| 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. |
Results Point of Contact:
Name/Title: Linmarie Sikich, M.D.
Organization: The University of North Carolina at Chapel Hill
phone: (919) 972-7499
e-mail: lsikich@med.unc.edu
Organization: The University of North Carolina at Chapel Hill
phone: (919) 972-7499
e-mail: lsikich@med.unc.edu
No publications provided
| Responsible Party: | Linmarie Sikich, MD, University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00617058 History of Changes |
| Other Study ID Numbers: | 05-3110 GCRC-2529 |
| Study First Received: | February 5, 2008 |
| Results First Received: | October 29, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |