Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females

Launched by UNIVERSITI PUTRA MALAYSIA · Sep 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of adding a medication called Aripiprazole to the treatment of females with certain mental health conditions, like schizophrenia or schizoaffective disorder. Many people who take antipsychotic medications experience weight gain and other metabolic issues as side effects, which can be challenging. The goal of this study is to see if Aripiprazole can help reduce these weight gain problems when used alongside other antipsychotics, like Olanzapine, Clozapine, or Risperidone.

To participate in this trial, females aged 18 to 65 who are currently taking stable doses of the mentioned antipsychotics may be eligible. However, pregnant or breastfeeding women, those with serious medical conditions affecting weight, or individuals with a history of negative reactions to Aripiprazole won't be able to take part. Participants will follow a study protocol and will be monitored for their weight and other health outcomes. This trial is currently not recruiting, but it aims to find safer treatment options for women managing their mental health alongside weight concerns.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females aged 18-65 years diagnosed with a mental health condition necessitating antipsychotic treatment.
• • Diagnosis of Schizophrenia or Schizoaffective Disorder
• • On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month
• • Willingness to comply with the study protocol.
• Exclusion Criteria:
• • Pregnancy or lactation.
• • Severe medical conditions impacting weight or metabolism.
• • Previous intolerance or contraindications to Aripiprazole.
• • Non-compliant with prescribed medications
• • Mental Retardation
• • Participant with an eating disorder
• • Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.
• • 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 Use of any medication for weight loss within the past one month to the study entry
• • Clinically significant abnormalities in physical examinations, ECG or lab assessments