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Trial record 79 of 1486 for:    child psychiatry

Improving Metabolic Parameters of Antipsychotic Child Treatment With Ziprasidone, Aripiprazole, and Clozapine (ZAC)

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ClinicalTrials.gov Identifier: NCT00617058
Recruitment Status : Terminated (Terminated in lieu of similar,competing large, multi-site study.)
First Posted : February 15, 2008
Results First Posted : December 31, 2012
Last Update Posted : December 31, 2012
Sponsor:
Collaborator:
Foundation of Hope, North Carolina
Information provided by (Responsible Party):
Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Weight Gain
Interventions Drug: metformin
Behavioral: healthy lifestyle intervention
Enrollment 1
Recruitment Details 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 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.
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description

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 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.

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.
Period Title: Overall Study
Started 1 0 0
Completed 1 0 0
Not Completed 0 0 0
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group Total
Hide Arm/Group Description

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 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.

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 of all reporting groups
Overall Number of Baseline Participants 1 0 0 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 0 participants 1 participants
<=18 years 1 1
Between 18 and 65 years 0 0
>=65 years 0 0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants 0 participants 0 participants 1 participants
17 17
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 0 participants 0 participants 1 participants
Female 0 0
Male 1 1
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 0 participants 0 participants 1 participants
1 1
1.Primary Outcome
Title Percent Change in BMI
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
-2.65
2.Primary Outcome
Title Absolute Change in Weight
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: lbs.
-10.6
3.Primary Outcome
Title Percent Change in Fat Mass
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
3.80
4.Primary Outcome
Title Percent Change in Weight
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
-4.00
5.Secondary Outcome
Title Percent Change in Insulin Levels
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
-23.08
6.Secondary Outcome
Title Percent Change in Total Cholesterol
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
2.84
7.Secondary Outcome
Title Percent Change in Triglycerides
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
46.60
8.Secondary Outcome
Title Incidence of Metabolic Syndrome
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: participants
0
9.Secondary Outcome
Title Percent Change in Glucose Levels
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
-3.41
10.Secondary Outcome
Title Percent Change in HDL
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
7.04
11.Secondary Outcome
Title Percent Change in LDL
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description:

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 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.

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.
Overall Number of Participants Analyzed 1 0 0
Measure Type: Number
Unit of Measure: percent change
-5.74
Time Frame Adverse event data were collected for the duration of the research study, which was a 6-month period.
Adverse Event Reporting Description 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.
 
Arm/Group Title Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Hide Arm/Group Description

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 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.

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.
All-Cause Mortality
Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Co-Treatment With Metformin Healthy Lifestyle Instruction Group Elective Monitoring Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/0   0/0 
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Linmarie Sikich, M.D.
Organization: The University of North Carolina at Chapel Hill
Phone: (919) 972-7499
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
First Submitted: February 5, 2008
First Posted: February 15, 2008
Results First Submitted: October 29, 2012
Results First Posted: December 31, 2012
Last Update Posted: December 31, 2012