Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics
Condition: Psychotic Disorders
MeSH terms: Weight Gain; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

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

Detailed description: 
      Disorders that involve severe dysregulation of mood or thoughts in children -- such as early
      onset bipolar spectrum (BPS) and schizophrenia spectrum (SS) disorders -- are commonly
      treated with antipsychotic medications. However, many of the newest and most commonly
      prescribed antipsychotic medications can cause weight gain and metabolic dysfunctions. Use of
      these newer antipsychotics, called second generation antipsychotics (SGAs), is increasing
      rapidly in children, and the risk of weight gain from SGAs is higher among children than
      adults. Excessive weight gain can lead to obesity, which, in turn, can lead to increased
      health care costs, increased risk of sickness, and lower life expectancy. These factors are
      enhanced in children and adolescents who grow up obese.

      Two different strategies to reduce weight gain and metabolic side effects from SGAs will be
      tested in this study. The first strategy involves switching from the current SGA to a lower
      risk agent (aripiprazole or perphenazine) hypothesized to result in weight loss and improved
      metabolic functioning. The second strategy involves taking the medication metformin in
      addition to the current SGA. Metformin is approved by the Food and Drug Administration (FDA)
      to promote weight loss in youth with diabetes and has been effective in reducing weight in
      youth taking SGAs.

      Participation in this study will last between 26 and 27 weeks and will be divided into two
      parts. The first part will last 2 to 3 weeks and include three study visits. During this
      part, participants will undergo a physical exam, an electrocardiogram (EKG), a dual energy
      X-ray absorptiometry (DXA) test, and blood tests. The DXA measures body fat.

      The second part will last 24 weeks and include nine study visits. During this part,
      participants will be randomly assigned to one of three conditions: gradual switch of current
      SGA medication to either aripiprazole or perphenazine, addition of metformin to current SGA
      medication, or no change to treatment with current SGA medication. Visits will take place on
      Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24. At each visit, participants will meet with a study
      doctor who will assess symptoms and side effects, and participants and their guardians will
      receive information and recommendations about childhood obesity and weight loss. There will
      also be monthly urine pregnancy tests, and two blood tests.
    

Intervention name(s): Aripiprazole or Perphenazine; Metformin; Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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 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.; Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated
Other intervention name(s): Abilify, Trilafon; Glucophage; Zyprexa, Seroquel, Risperdal, Geodon, Abilify, Saphris, Sycrest, Fanapt, Fanapta, Zomaril, Latuda, Invega, Symbyax
Intervention MeSH terms: Metformin; Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Paliperidone Palmitate; Ziprasidone; Lurasidone Hydrochloride; Asenapine; Iloperidone; Perphenazine; Fluoxetine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Weight Gain; Obesity; IMPACT; Antipsychotic Treatment; Excessive Weight Gain Associated With Antipsychotic Treatment; Hybrid Efficacy/Effectiveness Design; Reducing Weight Gain; Improving Metabolic Parameters; Aripiprazole; Metformin; Risperdal; Seroquel; Quetiapine; Olanzapine; Zyprexa; Geodon; Risperidone; Abilify; Trilafon; Perphenazine; Glucophage; Paliperidone; Olanzapine/fluoxetine