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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment |
|
| Control | No Intervention | No intervention will be given except usual antipsychotic treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in body weight in kilograms | Mean change in body weight measured by digital weight machine | 6-months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Body Mass Index (BMI) will be calculated by Body Mass Index (BMI) calculator | 6-months from baseline |
| Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels) |
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Inclusion Criteria:
Exclusion Criteria:
Females on antipsychotic medication
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sumbal Shehbaz, PhD | Contact | +92 331 4569159 | sumbal.shahbaz@dhpt.uol.edu.pk |
| Name | Affiliation | Role |
|---|---|---|
| MUHAMMAD ARSHED, PhD | University of Lahore | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22398127 | Result | 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. | |
| 17539698 | Result | Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9. |
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| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| D024821 | Metabolic Syndrome |
| D015430 | Weight Gain |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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Two-arm randomized control trial
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Participants and outcome assessors will be blinded.
Biochemical laboratory test
| 12 months from baseline |
| Change in waist circumference in cm | Change in waist circumference will be measured by an inch tape | 6-months from baseline |
| 27147592 | Result | 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. |
| 33800403 | Result | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |