Status:
NOT_YET_RECRUITING
Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females
Lead Sponsor:
Universiti Putra Malaysia
Conditions:
Psychosis
Metabolic Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
Brief Summary
Patients with psychiatric disorders, including depression, anxiety, and schizophrenia, often require antipsychotic medications for symptom management. However, metabolic changes, especially weight gai...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 10 2025
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06590298
Start Date
September 15 2024
End Date
April 10 2025
Last Update
September 19 2024
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