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

Phase 4

Not yet recruiting

• Conditions: Psychosis; Metabolic Syndrome; Weight Gain
• Interventions: Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

• Registration Number: NCT06590298
• Lead Sponsor: Universiti Putra Malaysia

Brief 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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-09-15
• Primary Completion: 2025-03-15
• Study Completion: 2025-04-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	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

Primary Outcome Measures

Name	Time	Method
Mean change in body weight in kilograms	6-months from baseline	Mean change in body weight measured by digital weight machine

Secondary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	6-months from baseline	Body Mass Index (BMI) will be calculated by Body Mass Index (BMI) calculator
Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)	12 months from baseline	Biochemical laboratory test
Change in waist circumference in cm	6-months from baseline	Change in waist circumference will be measured by an inch tape