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Not yet recruiting NCT06590298

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

Phase IV Interventional Psychosis Metabolic Syndrome Weight Gain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females.
Who it may be relevant to
Registry conditions: Psychosis, Metabolic Syndrome, Weight Gain. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial

Overview

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.

Interventions

  • Drug 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

Primary outcome measures

  • Mean change in body weight in kilograms [Time frame: 6-months from baseline]
Secondary outcome measures (3)
  • Body Mass Index (BMI) [Time frame: 6-months from baseline]
  • Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels) [Time frame: 12 months from baseline]
  • Change in waist circumference in cm [Time frame: 6-months from baseline]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 22398127
  • Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9. PMID 17539698
  • 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):71 PMID 27147592
  • 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. PMID 33800403

Identifiers

NCT: NCT06590298 · UIAT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗