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Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics (IMPACT)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Maryland
University of North Carolina, Chapel Hill
The Zucker Hillside Hospital
Information provided by (Responsible Party):
Mark Riddle, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00806234
First received: December 9, 2008
Last updated: April 21, 2017
Last verified: April 2017
Results First Received: July 2, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Outcomes Assessor;   Primary Purpose: Treatment
Condition: Psychotic Disorders
Interventions: Drug: Aripiprazole or Perphenazine
Drug: Metformin
Drug: Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Healthy Lifestyle Information

Participants will continue on current antipsychotic medication.

Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated

Switch Treatment + Healthy Lifestyle Instruction

Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.

Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels.

Metformin Treatment + Healthy Lifestyle Instruction

Participants will add metformin to current antipsychotic medication treatment.

Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere.


Participant Flow:   Overall Study
    Healthy Lifestyle Information   Switch Treatment + Healthy Lifestyle Instruction   Metformin Treatment + Healthy Lifestyle Instruction
STARTED   47   31   49 
COMPLETED   34   19   37 
NOT COMPLETED   13   12   12 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
127 subjects were randomized between 10/2009-10/2013 into three groups (CONTROL=47; MET=49; SWITCH=31). Safety analyses excluded 4 participants (CONTROL=1, MET=2, SWITCH=1) who discontinued at baseline. Primary efficacy analyses included 121 participants (CONTROL=44; MET=47; SWITCH=30) with ≥1 post-baseline vital sign measurement.

Reporting Groups
  Description
Healthy Lifestyle Information

Participants will continue on current antipsychotic medication.

Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated

Switch Treatment + Healthy Lifestyle Instruction

Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.

Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels.

Metformin Treatment + Healthy Lifestyle Instruction

Participants will add metformin to current antipsychotic medication treatment.

Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere.

Total Total of all reporting groups

Baseline Measures
   Healthy Lifestyle Information   Switch Treatment + Healthy Lifestyle Instruction   Metformin Treatment + Healthy Lifestyle Instruction   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   31   49   127 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      41  87.2%      26  83.9%      45  91.8%      112  88.2% 
Between 18 and 65 years      6  12.8%      5  16.1%      4   8.2%      15  11.8% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      17  36.2%      10  32.3%      18  36.7%      45  35.4% 
Male      30  63.8%      21  67.7%      31  63.3%      82  64.6% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      5  10.6%      4  12.9%      7  14.3%      16  12.6% 
Not Hispanic or Latino      42  89.4%      27  87.1%      42  85.7%      111  87.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      13  27.7%      9  29.0%      14  28.6%      36  28.3% 
White      25  53.2%      16  51.6%      26  53.1%      67  52.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      9  19.1%      6  19.4%      9  18.4%      24  18.9% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Body Mass Index (BMI) Z-score Change   [ Time Frame: Change from baseline to 24 weeks ]

2.  Secondary:   Change in Whole Body Insulin Sensitivity Index   [ Time Frame: Change from baseline to 24 weeks ]

3.  Secondary:   Triglyceride Levels   [ Time Frame: Change from baseline to 24 weeks ]

4.  Secondary:   Change in Low Density Lipoprotein (LDL) Cholesterol Level   [ Time Frame: From Baseline to Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
27 subjects were randomized between 10/2009-10/2013 into three groups (CONTROL=47; MET=49; SWITCH=31). Safety analyses excluded 4 participants (CONTROL=1, MET=2, SWITCH=1) who discontinued at baseline.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Mark Riddle
Organization: Johns Hopkins University
phone: 410-302-6120
e-mail: mriddle1@jhmi.edu


Publications:

Responsible Party: Mark Riddle, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00806234     History of Changes
Other Study ID Numbers: R01MH080270 ( US NIH Grant/Contract Award Number )
DSIR 84-CTS
Study First Received: December 9, 2008
Results First Received: July 2, 2016
Last Updated: April 21, 2017