Efficacy and Tolerability Study of Betahistine to Ameliorate Antipsychotic Associated Weight Gain
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Bipolar I Disorder; Bipolar II; Bipolar NOS(Not Otherwise Specified); Psychotic Disorder Not Otherwise Specified; Autism Spectrum Disorder
MeSH terms: Weight Gain; Schizophrenia; Autism Spectrum Disorder; Psychotic Disorders
Intervention: Betahistine; Placebo Oral Tablet
Intervention description: Subjects will be started on 8 mg BID of Betahistine and titrated up to 24 mg BID (BID = 2 times a day)..
Intervention MeSH terms: Betahistine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 59 Years
Healthy volunteers: No

Summary:

      The study attempts to evaluate a histamine analog long used for the treatment of Meniere's
      disease, betahistine, that shows promise in reversing the antihistaminergic effects thought
      to be involved in antipsychotic induced weight gain.

      Hypothesis to be tested:

      A. Patients who have gained a developmentally inappropriate amount of weight on
      antipsychotics (AP) will see their weight and BMI decrease with betahistine augmentation as
      compared to placebo augmentation.

      B. Betahistine augmentation in AP treated patients will increase levels of satiety in a
      standardized meal situation and decrease caloric intake as compared to placebo augmentation.

      C. Metabolic effects of betahistine augmentation in AP treated patients will be reflected in
      differences in waist circumference, hip circumference and waist hip ratios D. Betahistine
      augmentation in this population will lead to decrease in fasting glucose-lipid lab values
      related to the development of metabolic syndrome as compared to placebo augmentation
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescents and Adults ages 12-59 with a diagnosis of Schizophrenia, Schizoaffective
             Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder
             NOS, Autism Spectrum Disorder

          -  Patients will be currently treated with antipsychotics

        Patients will qualify for entry if they meet the following weight criteria:

          1. The patient has gained 7% of their weight since beginning of treatment with one or
             more of the current antipsychotics.

          2. The patient has had an increase of 7% of their weight during the last year while being
             treated with antipsychotics.

          3. The patient has a BMI of 30 or more and has gained 10 lbs or more in the past 8 months
             while being treated with antipsychotic medications.

          4. The patient has a BMI of 35 or greater at the current time, and his chart shows a
             history of consistent weight gain over the past 1 to 3 years during treatment with
             antipsychotics.

             .

             Exclusion Criteria:

               -  Subjects will be excluded if they have asthma, peptic ulcer disease (diseases
                  which may be exacerbated by a histamine analog), or history of pheochromocytoma
                  or peptic ulcer disease. Patients will be excluded if they are prescribed
                  medications known to affect body weight or glucose-lipid metabolism, such as
                  prescription or over the counter medications taken for the purpose of weight
                  reduction. Subjects who are currently treated with metformin, for less than 6
                  months and have shown recent weight change on metformin. Patients on thyroid
                  replacement therapy or lipid-lowering agents whose dosage has changed by more
                  than 50 % in the past month will be excluded. If they are relatively stable doses
                  of these medications they will not be excluded. Patients who are on lipid
                  lowering medication, thyroid replacement medication, or diabetes medication,
                  (excluding metformin), must remain on these medications throughout the period of
                  the study. Females who are pregnant or breast feeding will be excluded.