Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202108856656364 Date of Approval: 24/08/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomised Controlled Trial of Omega 3 Fatty Acids in the Management of Antipsychotic-Induced Movement Disorders
Official scientific title A Randomised Controlled Trial of Omega 3 Fatty Acids in the Management of Antipsychotic-Induced Movement Disorders
Brief summary describing the background and objectives of the trial Despite the therapeutic benefits of antipsychotic medications, their use is limited by movement side effects. These increase the risk of non-adherence and serve as a barrier to positive therapeutic outcomes. Omega 3 fatty acids confer neuroprotection and may be beneficial in preventing motor complications associated with antipsychotic use. Limited data is available in Ghana regarding the impact of omega 3 fatty acids in the management of antipsychotic-induced movement disorders(AIMD) The study shall seek to determine the efficacy and safety of omega 3 fatty acids in the management of AIMD and to understand other complementary and alternative therapies patients engage with.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/11/2021
Actual trial start date
Anticipated date of last follow up 02/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Omega 3 fish oil 1000mg daily dose 24weeeks The Omega 3 fatty acids shall come in soft gelatin capsules and shall be prefilled with the fish oil in transparent gelcaps to enhance delivery. The active ingredient shall be mixed with tocopherol (vitamin E) to prevent oxidation. 60
Control Group Artane 5mg daily dose 24weeks The oral preparations come in small white-colored tablets that can be swallowed easily 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
A confirmed diagnosis of antipsychotic-induced movement disorder Participants aged between 18 and 60years. On a stable dose of antipsychotic medication within 3 months prior to study Patients in the control arm should not have initiated anti-cholinergic therapy Patients should demonstrate a commitment not to initiate or modify interventions during the period of the study. Patients whose psychiatric disorder was not stable; Patients with a significant organic neurological disorder other than the mental disorder Treatment with omega-3 therapy 3months prior to study Patients who were pregnant or breastfeeding. Patients with a diagnosis of substance dependence (DSM-IV), Patients with a known allergy to omega 3 fish oil or sea foods Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 13/09/2021 Ethics Review Committee Research and Development Division
Ethics Committee Address
Street address City Postal code Country
Ghana Health Service Ethical Review Committee-Research and Development Division, Castle road, Accra. Accra Box 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Assessment of the efficacy and safety of omega 3 1000mg polyunsaturated fatty acid therapy in reducing the severity of symptoms in patients experiencing antipsychotic-induced movement disorders after 24 weeks of supplementation Every 2weeks for 24weeks
Secondary Outcome Determine the correlations between omega 3 supplementation and clinical outcomes of therapy after intervention Every 2weeks for 24weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Accra Psychiatric Hospital Accra Psychiatric Hospital Castle Road Accra Accra Box 1305. Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
DEBRAH AKOSUA BEMA DEBRAHKROM STREET KOFORIDUA BOX 152 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Sammy Ohene Harley Street, Accra Accra Ghana ACADEMIC SUPERVISOR
COLLABORATORS
Name Street address City Postal code Country
Dr Augustina Pinaman Appau Castle Road, Accra Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Akosua Debrah akodebscriptures@yahoo.co.uk +233207774753 Debrahkrom street
City Postal code Country Position/Affiliation
Koforidua Box 152 Ghana Postgraduate Student Kwame Nkrumah University of Science and Technology
Role Name Email Phone Street address
Scientific Enquiries Sammy Ohene sammyohene@gmail.com +233202110283 Harley street, Accra
City Postal code Country Position/Affiliation
Accra BOX 77 Ghana Consultant Psychiatrist Korle Bu Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Frances Owusu Daaku frances.owusudaaku@gmail.com +233208137245 Knust Street
City Postal code Country Position/Affiliation
Kumasi Ghana Professor Kwame Nkrumah University of Science and Technology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers with an academic interest in mental health interventions. Data shared will be coded, with no participant identification and contacts included. Approval of the request from the study sponsor shall be a prerequisite to sharing data with the requesting party. Clinical Study Report,Informed Consent Form Data requests can be submitted 6 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) as well as execution of a Data Sharing Agreement (DSA). For more information on how to submit a request, please contact akodebscriptures@yahoo.co.uk
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information