PsychosisPhase 4NCT06590298
Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females
A Phase 4 study testing Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females in people with Psychosis and Metabolic Syndrome, run by Universiti Putra Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Psychosis, Metabolic Syndrome, Weight Gain
- What is being tested?
- Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2024to 10 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial
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.
Read the 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
- Being tested
- Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females
- Medical subject headings
- Psychotic Disorders, Metabolic Syndrome, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in FemalesDrug
The intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females |
| Control | No intervention | No intervention will be given except usual antipsychotic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in body weight in kilograms
Mean change in body weight measured by digital weight machine
Measured: 6-months from baseline
Secondary outcomes (3)
Body Mass Index (BMI)
Body Mass Index (BMI) will be calculated by Body Mass Index (BMI) calculator
Measured: 6-months from baseline
Metabolic markers (fasting blood glucose; HbA1c; triglycerides; total, HDL and LDL cholesterol levels)
Biochemical laboratory test
Measured: 12 months from baseline
Change in waist circumference in cm
Change in waist circumference will be measured by an inch tape
Measured: 6-months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arshed Muhammad, Universiti Putra Malaysia
- Investigators
- MUHAMMAD ARSHED, PhD, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590298
- Sponsor's protocol ID
- UIAT
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 22398127Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9.
PubMed 17539698Cooper 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.
PubMed 27147592Carli 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.
PubMed 33800403
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effects of Adjunctive Aripiprazole on Weight and Metabolic Outcomes in Females Receiving Atypical Antipsychotics: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06590298
- Acronym / sponsor ID
- UIAT
- Conditions
- Psychosis, Metabolic Syndrome, Weight Gain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in FemalesThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- Pregnancy or lactation.
- Severe medical conditions impacting weight or metabolism.
- Previous intolerance or contraindications to Aripiprazole.
- Non-compliant with prescribed medications
- Mental Retardation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in FemalesThe intervention group will be added 5 mg of aripiprazole as an adjunct with the usual antipsychotic treatment to the females on antipsychotic treatment | Drug | Intervention group |
Primary outcome
Mean change in body weight in kilograms
Time frame: 6-months from baseline
Mean change in body weight measured by digital weight machine
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 22398127Wang 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.
- Results publication: PubMed 17539698Weiden PJ. Switching antipsychotics as a treatment strategy for antipsychotic-induced weight gain and dyslipidemia. J Clin Psychiatry. 2007;68 Suppl 4:34-9.
- Results publication: PubMed 27147592Cooper 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.
- Results publication: PubMed 33800403Carli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MUHAMMAD ARSHED, PhD principal investigator
University of Lahore
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjunctive Aripiprazole for improving Weight and Metabolic Outcomes in Females in people with Psychosis and Metabolic Syndrome, run by Universiti Putra Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sumbal Shehbaz, PhD (+92 331 4569159, sumbal.shahbaz@dhpt.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in body weight in kilograms (time frame: 6-months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06590298, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.