CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 127 enrolled
Drug / intervention
Aripiprazole or Perphenazine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00806234
NCT00806234Phase 4Completed
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Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT)

Johns Hopkins University·interventional·Posted Dec 10, 2008·Updated Apr 25, 2017

In Brief

A Phase 4 clinical trial evaluating Aripiprazole or Perphenazine, Metformin, and 1 other intervention for Psychotic Disorders. Completed, enrolled 127 participants across 4 sites.

Detailed Summary

This study will test the effectiveness of two different treatments for children and adolescents who have gained weight on their antipsychotic medications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsychotic Disorders
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH), University of Maryland, University of North Carolina, Chapel Hill, The Zucker Hillside Hospital

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2008
Enrollment StartJan 1, 2009
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 17.6 years ago

Interventions

Aripiprazole or Perphenazinedrug

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.

Metformindrug

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.

Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetinedrug

Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated