| CTRI Number |
CTRI/2024/10/074931 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
08/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Does melatonin help ADHD kids sleep better and think clearer |
|
Scientific Title of Study
|
To study the effectiveness of melatonin supplementation on sleep and cognition in children with ADHD experiencing sleep disturbances |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritwick Tripathi |
| Designation |
Junior Resident |
| Affiliation |
King George medical university |
| Address |
Resident room
Ground floor
Department of psychiatry
gate no 11
King george medical university
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8765923228 |
| Fax |
|
| Email |
ritvick97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Vivek Agarwal |
| Designation |
Professor and Head |
| Affiliation |
King George medical university |
| Address |
Head of Department
Ground floor chamber
Department of psychiatry
gate no 11
King George medical university
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839287480 |
| Fax |
|
| Email |
drvivekagarwal06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritwick Tripathi |
| Designation |
Junior Resident |
| Affiliation |
King george medical university |
| Address |
Resident room
ground floor
Department of psychiatry
gate no 11
King George medical university
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8765923228 |
| Fax |
|
| Email |
ritvick97@gmail.com |
|
|
Source of Monetary or Material Support
|
| King george medical university
Shah mina road
Chowk
Lucknow
Uttar pradesh
India
226003 |
|
|
Primary Sponsor
|
| Name |
King george medical university |
| Address |
King george medical university, Lucknow, Uttar Pradesh, 226003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ritwick Tripathi |
King george medical university |
Child and adolescent psychiatry opd
Department of psychiatry
king george medical university
lucknow
Lucknow
UTTAR PRADESH |
8765923228
ritvick97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King george medical university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Melatonin will be supplemented in doses of 3mg or 5mg according to body weight using oral tablets and response will be studied over a total duration of 6 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with ADHD willing to participate after taking a written informed consent from the primary caregiver with the assent of the patient
Children between ages 6 and 16 years
Experiencing sleep disturbances assessed using a cutoff score of 41 on the CSHQ scale
Treatment for ADHD continued as usual on stable dose of medication for past 4 weeks |
|
| ExclusionCriteria |
| Details |
Children diagnosed with intellectual disability
Children diagnosed with autism spectrum disorder
Children diagnosed with epilepsy or any other neurological condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Melatonin supplementation will improve sleep and cognition among children aged 6 to 16 years diagnosed with Attention-Deficit/Hyperactivity disorder experiencing Sleep disturbances |
Baseline
2 weeks
4 weeks
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/10/2024 |
| Date of Study Completion (India) |
10/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ritvick97@gmail.com].
- For how long will this data be available start date provided 10-09-2026 and end date provided 10-09-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To investigate the effectiveness of melatonin treatment on sleep and cognition in children aged 6 to 16 years with attention deficit hyperactivity disorder with sleep problems attending child and adolescent psychiatry OPD Melatonin
supplementation will improve sleep and cognition among children aged 6 to 16
years diagnosed with Attention Deficit Hyperactivity
disorder experiencing Sleep
disturbances |