Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile

NCT02949752 | Completed Phase 4 DMC

• 1 other identifier: 518-2015
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label study to prospectively evaluate the effect of adjunct use of Aripiprazole, as an agent to improve metabolic profile and induce weight loss in patients established on atypical antipsychotics (Olanzapine, Clozapine and Risperidone).

Conditions

Antipsychotics Weight Gain

Outcome Measures

Primary Outcomes (1)

• Mean change in body weight in kilograms

  To assess mean change in body weight from baseline to week 12 in patients receiving adjunctive Aripiprazole to atypical antipsychotic therapy, i.e. olanzapine, clozapine, risperidone.

  12 weeks, assessed at baseline and at final follow up at week 12

Secondary Outcomes (6)

• Change in waist circumference in cm

  12 weeks, assessed at baseline and at final follow up at week 12

• Number of participants with treatment-related adverse events as assessed by Side Effects Checklist

  Checklist completed every two weeks, for the study duration of 12 weeks via Face to Face interview or Telephone contact

• Number of participants with improvement or deterioration in neuro-cognition as assessed by Digit Sequencing Test and Symbol Coding Test

  12 weeks, assessed at baseline and at final follow up at week 12

• Change in fasting plasma glucose mg/dl from baseline to week 12

  12 weeks, assessed at baseline and at final follow up at week 12

• Change in Total Cholesterol, LDL and HDL Cholesterol mg/dl from baseline to week 12

  12 weeks, assessed at baseline and at final follow up at week 12

Study Arms (1)

Aripiprazole Adjunct

EXPERIMENTAL

Aripiprazole 5 mg as a fixed dose as adjunct to other antipsychotics

Drug: Aripiprazole

Interventions

Aripiprazole DRUG

Aripiprazole 5 mg every morning will be prescribed for 12 weeks

Aripiprazole Adjunct

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female patients (21 to 65 yrs)
• Diagnosis of Schizophrenia or Schizoaffective Disorder
• Outpatients
• On stable doses of atypical antipsychotics, either Olanzapine, Clozapine, or Risperidone for at least 1 month
• Patients can be on other concomitant medications. Patients can be on antipsychotic polypharmacy, but there should not be more than 1 of the above 3 atypicals in a single prescription.
• Patients should be able to provide written informed consent.
• Currently with a BMI ≥ 25 (Overweight) and/or ≥7% increase in weight from pre-antipsychotic treatment.

You may not qualify if:

• Previous allergy to Aripiprazole/contraindication to use of Aripiprazole
• Participants with current substance misuse, including alcohol but excluding tobacco.
• Non-compliant with prescribed medications
• Mental Retardation
• Presence of any major or unstable medical or neurological illness (such as uncontrolled diabetes and hypertension).
• Participant with an eating disorder
• Participants with serious suicidal thoughts, or who pose a serious risk of harm to self or to others.
• Women who are pregnant or breastfeeding
• Severe Personality Disorder
• 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
• Baseline BMI \< 18.5kg/m2 (cut-off point for underweight adults as per World Health Organisation guidelines)
• Unable to read or speak English

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead

Study Sites (1)

Institute of Mental Health

Singapore, 556121, Singapore

Location

Related Publications (2)

• Fleischhacker WW, Heikkinen ME, Olie JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12.

  PMID: 20459883 BACKGROUND

• Gupta B, Chee KS, Neo LQ, Tang C, Hariram J, Tan GC, Verma S, Basu S, Appan DP, Ting CC, Abdin E, Lee J. Effect of aripiprazole as an adjunct to atypical antipsychotics on weight and metabolic profile: a 12-week open-label trial. Ther Adv Psychopharmacol. 2021 Oct 9;11:20451253211046765. doi: 10.1177/20451253211046765. eCollection 2021.

  PMID: 34646440 DERIVED

MeSH Terms

Interventions

Aripiprazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bhanu Gupta, MRCPsych

  Institute of Mental Health, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Psychiatrist

Study Record Dates

• First Submitted: October 4, 2016
• First Posted: October 31, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)