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NCT Number: NCT06590298

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

Drug

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 outcomes

  1. Mean change in body weight in kilograms

    Time frame: 6-months from baseline

    Mean change in body weight measured by digital weight machine

Secondary outcomes

  1. Body Mass Index (BMI)

    Time frame: 6-months from baseline

    Body Mass Index (BMI) will be calculated by Body Mass Index (BMI) calculator

  2. Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)

    Time frame: 12 months from baseline

    Biochemical laboratory test

  3. Change in waist circumference in cm

    Time frame: 6-months from baseline

    Change in waist circumference will be measured by an inch tape

Study contacts

Contact information is provided by the study sponsor or research team.

Sumbal Shehbaz, PhD

CONTACT

[email protected]

+92 331 4569159

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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