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

NCT ID: NCT06590298

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-15
• Study Completion Date: 2025-04-10

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.

Conditions

Psychosis; Metabolic Syndrome; Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment

Group Type: EXPERIMENTAL

Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

Intervention Type: 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

Control

No intervention will be given except usual antipsychotic treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females

The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment

Intervention Type: DRUG

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 > 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

Arshed Muhammad

PhD studentship

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MUHAMMAD ARSHED, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Central Contacts

Sumbal Shehbaz, PhD

Role: CONTACT

sumbal.shahbaz@dhpt.uol.edu.pk

+92 331 4569159

References

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.

Reference Type: BACKGROUND

PMID: 22398127 (View on PubMed)

Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9.

Reference Type: BACKGROUND

PMID: 17539698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27147592 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33800403 (View on PubMed)

Other Identifiers

UIAT

Identifier Type: -

Identifier Source: org_study_id