Clinical trial NCT06590298: Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females
Official title: Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Psychosis
Metabolic Syndrome
Weight Gain
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized control trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 \&gt; 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

Primary outcomes:
measure: Mean change in body weight in kilograms
timeFrame: 6-months from baseline
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 6-months from baseline
measure: Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)
timeFrame: 12 months from baseline
measure: Change in waist circumference in cm
timeFrame: 6-months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Lahore
name: MUHAMMAD ARSHED, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang M, Tong JH, Zhu G, Liang GM, Yan HF, Wang XZ. Metformin for treatment of antipsychotic-induced weight gain: a randomized, placebo-controlled study. Schizophr Res. 2012 Jun;138(1):54-7. doi: 10.1016/j.schres.2012.02.021. Epub 2012 Mar 5.
citation: Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9.
citation: Cooper SJ, Reynolds GP; With expert co-authors (in alphabetical order):; Barnes T, England E, Haddad PM, Heald A, Holt R, Lingford-Hughes A, Osborn D, McGowan O, Patel MX, Paton C, Reid P, Shiers D, Smith J. BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment. J Psychopharmacol. 2016 Aug;30(8):717-48. doi: 10.1177/0269881116645254. Epub 2016 May 4.
citation: Carli M, Kolachalam S, Longoni B, Pintaudi A, Baldini M, Aringhieri S, Fasciani I, Annibale P, Maggio R, Scarselli M. Atypical Antipsychotics and Metabolic Syndrome: From Molecular Mechanisms to Clinical Differences. Pharmaceuticals (Basel). 2021 Mar 8;14(3):238. doi: 10.3390/ph14030238.