Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile

• Status: Completed
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open label study to prospectively evaluate the effect of adjunct use of Aripiprazole, as an agent to improve metabolic profile and induce weight loss in patients established on atypical antipsychotics (Olanzapine, Clozapine and Risperidone).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Mental Health, Singapore
• Treatments: Antipsychotic Agents; Aripiprazole

Criteria

Inclusion Criteria:

1. Adult male or female patients (21 to 65 yrs)

2. Diagnosis of Schizophrenia or Schizoaffective Disorder

3. Outpatients

4. On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month

5. Patients can be on other concomitant medications. Patients can be on antipsychotic polypharmacy, but there should not be more than 1 of the above 3 atypicals in a single prescription.

6. Patients should be able to provide written informed consent.

7. Currently with a BMI ≥ 25 (Overweight) and/or ≥7% increase in weight from pre-antipsychotic treatment.

Exclusion Criteria:

1. Previous allergy to Aripiprazole/contraindication to use of Aripiprazole

2. Participants with current substance misuse, including alcohol but excluding tobacco.

3. Non-compliant with prescribed medications

4. Mental Retardation

5. Presence of any major or unstable medical or neurological illness (such as uncontrolled diabetes and hypertension).

6. Participant with an eating disorder

7. Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.

8. Women who are pregnant or breastfeeding

9. Severe Personality Disorder

10. Diagnosis of Hyper or Hypothyroidism; Evidence of thyroid dysfunction as evidenced by serum thyroid function tests (i.e Thyroid Stimulating Hormone and Free Thyroxine (fT4) levels > 10 % above or below the limits of the normal range

11. Use of any medication for weight loss within the past one month to the study entry

12. Clinically significant abnormalities in physical examinations, ECG or lab assessments

13. Baseline BMI < 18.5kg/m2 (cut-off point for underweight adults as per World Health Organisation guidelines)

14. Unable to read or speak English