Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT00806234
Eligibility Criteria:
Inclusion Criteria:
* DSM diagnoses that have an FDA indication for atypical antipsychotic use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of Early Onset Schizophrenia Spectrum (EOSS; schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS); Bipolar Spectrum (bipolar I, II and NOS); Major depressive disorder with psychosis; Mood disorder NOS corresponding to Leibenluft and colleagues severely mood dysregulated (SMD) broad spectrum bipolar disorder; Mood disorder NOS corresponding to irritability associated with autism spectrum disorders; or - for adult teen participants aged 18-19 years - Major depressive disorder. Diagnoses will be determined by clinical interview, Leibenluft's modification of the K-SADS-PL, and the "Aberrant Behavior Checklist" (cutoff score of 18, as used by FDA for approval of risperidone and aripiprazole in minors).
* Clinically stable on current treatment regimen for at least 30 days, as assessed in a three-step process
* Current SGA treatment with olanzapine, quetiapine, risperidone, ziprasidone aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine for ≥ 8 weeks
* Stable dose of current SGA and psychotropic co-medications for at least 30 days
* Body mass index (BMI) at least in the 85th percentile for age and gender
* Substantial weight gain over the previous 3 years while taking a SGA, as reflected by family and referring physician's judgment. The weight gain did not have to occur on the child's current SGA. Weight needs to have remained stable or increased over past year.
* Agrees to use two effective forms of birth control or to remain abstinent
* Has a primary caretaker who has known the child well for at least 6 months before study entry
* Primary caretaker is able to participate in study appointments as clinically indicated
Exclusion Criteria:
* Treatment with any medication (other than the currently prescribed psychotropic medications) that would significantly alter glucose, insulin, or lipid levels. Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss.
* Major neurological or medical illness that affects weight gain or that would prevent participation in physical activities
* Fasting glucose levels indicating need for prompt treatment
* Pediatrician or pediatric gastroenterologist recommendation to address abnormal fasting labs by pursuing more active treatment than those in the 2007 American Medical Association guidelines
* Diagnosis of anorexia nervosa or bulimia nervosa, as based on current or lifetime DSM-IV criteria
* Diagnosis of substance dependence disorder (other than tobacco dependence) within the past month, as based on DSM-IV criteria
* Positive urine toxicology indicating ongoing use of illicit substance
* Current treatment with more than one antipsychotic medication
* Current treatment with more than 3 total psychotropic medications (i.e., 2 psychotropics plus SGA), with the exception of subjects taking 2 medications for ADHD in which a total of 4 psychotropic medications are allowed.
* Known hypersensitivity to metformin
* Prior treatment with aripiprazole and perphenazine for more than 2 weeks that was stopped for inefficacy or intolerability
* Pregnant, breastfeeding, or unwilling to comply with contraceptive requirements of study
* IQ score less than 55
* Significant risk of dangerousness to self or to others that would make study participation inadvisable
* Language issues that prevent child and/or parent from completing assessments or treatment
* Ongoing or previously undisclosed child abuse requiring new department of social service intervention
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
19 Years
Study:
NCT00806234
Study Brief:
Protocol Section:
NCT00806234