NCT06590298

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

Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: Universiti Putra Malaysia · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gain, are a common and challenging side effect of many antipsychotics. Aripiprazole, an atypical antipsychotic, has shown promise in mitigating this adverse effect when used in combination with other antipsychotic medications.

Detailed description

This study aims to investigate the effectiveness of different combinations of aripiprazole with atypical antipsychotics in preventing or minimizing weight gain in patients with various psychiatric conditions. While weight gain affects both genders, females may be particularly vulnerable due to physiological differences and societal pressures related to body image. Collectively, while individual studies have specific nuances, the general trend suggests that combining Aripiprazole with dietary modifications and potentially lifestyle changes shows promise in managing weight gain associated with antipsychotic medications in females.

Conditions

• Psychosis
• Metabolic Syndrome
• Weight Gain

Interventions

Type	Name	Description
DRUG	Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females	The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment

Timeline

• Start date: 2024-09-15
• Primary completion: 2025-03-15
• Completion: 2025-04-10
• First posted: 2024-09-19
• Last updated: 2024-09-19