Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversiti Putra Malaysia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnancy or lactation.
Severe medical conditions impacting weight or metabolism.
Previous intolerance or contraindications to Aripiprazole.
Non-compliant with prescribed medications
Trial design
Design model
Parallel
Treatments tested in this trial
Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females
DrugThe intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Mean change in body weight in kilograms
Mean change in body weight measured by digital weight machine
Time frame
6-months from baselineSecondary outcomes
1
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated by Body Mass Index (BMI) calculator
Time frame
6-months from baseline2
Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)
Biochemical laboratory test
Time frame
12 months from baseline3
Change in waist circumference in cm
Change in waist circumference will be measured by an inch tape
Time frame
6-months from baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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