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CTRI Number  CTRI/2025/10/096489 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 26/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study to evaluate benefit of modafinil in adolescents with poor intelligence 
Scientific Title of Study   Comparison of efficacy of oral modafinil in improving cognition in adolescents with intellectual disability aged 10-18 years: a double-blind, randomized, placebo-controlled trial 
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 Prateek Kumar Panda 
Designation  Associate Professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of Pediatrics, 6th Floor, A Block

Dehradun
UTTARANCHAL
249203
India 
Phone  9650149735  
Fax    
Email  drprateekpanda@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prateek Kumar Panda 
Designation  Associate Professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of Pediatrics, 6th Floor, A Block


UTTARANCHAL
249203
India 
Phone  9650149735  
Fax    
Email  drprateekpanda@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Prateek Kumar Panda 
Designation  Associate Professor 
Affiliation  AIIMS, Rishikesh 
Address  Department of Pediatrics, 6th Floor, A Block


UTTARANCHAL
249203
India 
Phone  9650149735  
Fax    
Email  drprateekpanda@gmail.com  
 
Source of Monetary or Material Support  
Department of Science and Technology, Technology Bhavan, New Mehrauli Rd, Block C, Qutab Institutional Area, New Delhi, Delhi 110016 
 
Primary Sponsor  
Name  Department of Science and Technology 
Address  Technology Bhavan, New Mehrauli Rd, Block C, Qutab Institutional Area, New Delhi, Delhi, 110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prateek Kumar Panda  All India Institute of Medical Sciences, Rishikesh  Pediatric Neurology Division, Department of Pediatrics, 6th Floor, A Block
Dehradun
UTTARANCHAL 		 9650149735

drprateekpanda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Rishikesh Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modafinil  oral 100 mg one tablet once daily for one week and then one tablet twice daily for next 11 weeks  
Comparator Agent  Placebo  One tablet once daily for one week and then one tablet twice daily for next 11 weeks 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Adolescents with mild and moderate intellectual disability (full-scale IQ between 35 and 70) 
 
ExclusionCriteria 
Details  Already receiving any stimulant or non-stimulant medication for hyperactivity (atomoxetine, methylphenidate, clonidine) or any typical or atypical antipsychotic
Suffering from uncontrolled epilepsy (seizure within one month before enrolment) or receiving any medication for seizures, movement disorder or spasticity
Severe hearing or vision impairment, which impairs accurate interpretation of subtests employed in MISIC
Chronic cardiac, pulmonary, renal, hepatic or gastrointestinal illness
Already receiving modafinil or have received modafinil previously
Satisfying DSM-5 criteria for autism spectrum disorder
Parents or adolescents not giving informed consent
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Full-scale intelligence quotient  At 0 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Vanderbilt ADHD Diagnostic Parent Rating Scale  At 0 and 12 weeks 
Adolescent Sleep Hygiene Scale score   At 0 and 12 weeks 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This RCT will be a double blind placebo-controlled trial exploring the efficacy of oral modafinil for 12 weeks as compared to a matching placebo in improving full-scale intelligence quotient in adolescents with mild and moderate intellectual disability. Each participant will be randomised to receive either modafinil or a placebo for 12 weeks. Variable block randomisation and allocation concealment by serially numbered sealed opaque envelopes will be used. We will also assess the change in the Vanderbilt ADHD diagnostic parent rating scale and adolescent sleep hygiene scale at 12 weeks as compared to baseline in both groups as secondary objectives. 
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