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

University of Putra Malaysia (UPM)

Status and phase: Not yet enrolling; Phase 4

Conditions: Weight Gain; Psychosis; Metabolic Syndrome

Treatments: Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

Study type: Interventional

Funder types: Other

Identifiers

NCT06590298

UIAT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment

Treatment:

Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

Control

No Intervention group

Description:

No intervention will be given except usual antipsychotic treatment