Neurology & Psychiatry Clinical Research · India
Neurology and Psychiatry Clinical Trials in India
Shen Clinical Services runs neurology clinical trials in India, along with psychiatry and other CNS studies, from Phase I to Phase IV. We cover Alzheimer’s disease, Parkinson’s disease, stroke, epilepsy, migraine, depression and schizophrenia, with protocol design, CDSCO and ethics approvals, site selection, rater training, data management and safety reporting.
8.2%Of India’s disease burden is neurological
10.6%Of adults have a mental disorder
8.8 millionPeople aged 60+ with dementia
90 working daysCDSCO trial decision
On this page
Why India
Why Run CNS Clinical Trials in India
CNS is one of the fastest-growing areas of clinical research, and India’s neurological and mental health needs are rising fast.
Rising Neurological Burden
Neurological disorders grew from 4% to 8.2% of India’s disease burden between 1990 and 2019, and stroke causes 7.4% of all deaths.
Mental Health Need
The National Mental Health Survey found mental disorders in about 10.6% of adults, with around 1 in 20 people living with depression.
Ageing Population
An estimated 7.4% of Indians aged 60 and over, about 8.8 million people, live with dementia.
Time-Bound Approvals
CDSCO decides on a trial application within 90 working days, or 30 working days for drugs discovered and developed in India.
Indications
CNS Indications and Endpoints We Cover
We design and run neurology and psychiatry clinical research across these areas:
| Indication | Typical studies | Common endpoints |
|---|---|---|
| Alzheimer’s disease and dementia | Disease-modifying and symptomatic trials | ADAS-Cog, CDR-SB, MMSE; amyloid and tau biomarkers |
| Parkinson’s disease | Symptomatic and disease-modifying trials | MDS-UPDRS; daily OFF time |
| Stroke | Acute treatment, recovery and secondary prevention | Modified Rankin Scale; recurrent stroke |
| Epilepsy | Adjunctive therapy trials | Seizure frequency reduction; 50% responder rate |
| Migraine | Acute and preventive treatment trials | Monthly migraine days; pain freedom at 2 hours |
| Depression and anxiety | Antidepressant and anxiolytic trials | MADRS, HAM-D, HAM-A |
| Schizophrenia and bipolar disorder | Antipsychotic and mood stabiliser trials | PANSS; YMRS |
Trial Operations
How We Run Neurology Clinical Trials and Psychiatry Studies
CNS trials rely on subjective scales, vulnerable participants and long follow-up. We set up and manage:
- Neurology and psychiatry sites: investigators at neurology, psychiatry and memory clinics across India
- Rater training: certification and consistency checks on cognitive, motor and psychiatric scales
- Language validation: validated scales and consent forms in the languages participants speak
- Protective consent: legally acceptable representatives and audio-video recording where required
- Safety monitoring: structured suicidality assessment and close adverse event follow-up
- Imaging and EEG: MRI, PET and EEG coordination with central reading
- Approvals: CDSCO permission in Form CT-04/CT-06, ethics approvals and CTRI registration
Learn more about our clinical trial protocol design and clinical data management services.
Our Process
How We Deliver Your CNS Trial
STEP 01
Feasibility and Sites
We check patient numbers and standard of care, then select neurology and psychiatry sites.
STEP 02
Protocol and Approvals
We write the protocol and file for CDSCO permission, ethics approvals and CTRI registration.
STEP 03
Conduct and Monitor
We train raters, start up sites and monitor consent, scoring, dosing and source data.
STEP 04
Data, Safety and Reports
We manage data, report serious adverse events on time and deliver the study report.
Why Shen
Why Choose Shen as Your CNS CRO in India
Physician-Led Oversight
Medically qualified team members review protocols, eligibility, consent and safety signals throughout the study.
Regulatory Under One Roof
The same team handles CDSCO, ethics and CTRI filings through our regulatory affairs services.
CNS Site Network
We work with neurologists, psychiatrists and memory clinics across India.
One Partner, Full Service
Monitoring, data management, pharmacovigilance and medical writing from a single team.
What We Cover
Our Neurology and Psychiatry Clinical Research Services
Feasibility and site selection
Protocol and study design
CDSCO trial permission
Ethics committee submissions
CTRI registration
Site start-up and monitoring
Rater training and certification
Scale and consent translation
Imaging and EEG coordination
Clinical data management
Pharmacovigilance and SAE reporting
Medical writing and CSRs
FAQs
Neurology Clinical Trials in India: Frequently Asked Questions
Why run neurology and psychiatry trials in India?
India has a large and growing CNS patient population. Neurological disorders now account for 8.2% of India’s total disease burden, up from 4% in 1990, about 10.6% of adults have a mental disorder, and an estimated 8.8 million people aged 60 and over live with dementia. A time-bound CDSCO approval process supports timely study start-up.
How is consent handled for patients with dementia or severe mental illness?
Where a participant cannot give informed consent, a legally acceptable representative consents on their behalf, and the participant’s assent is sought where possible. The NDCT Rules require audio-video recording of consent for vulnerable participants, and the Mental Healthcare Act, 2017 adds safeguards for research involving people with mental illness.
How do you reduce placebo response in psychiatric trials?
We train and certify raters on each scale, check scoring consistency across sites, apply strict eligibility criteria and keep visit procedures consistent. Independent or blinded raters can be used where the protocol needs them.
Which rating scales are used in CNS trials?
Common scales include ADAS-Cog and CDR-SB for Alzheimer’s disease, MDS-UPDRS for Parkinson’s disease, the modified Rankin Scale for stroke, MADRS and HAM-D for depression, and PANSS for schizophrenia. We use validated versions in the languages participants speak.
How long does CDSCO take to approve a CNS trial?
Under Rule 22 of the New Drugs and Clinical Trials Rules, 2019, CDSCO decides on a clinical trial application within 90 working days. For drugs discovered in India, or researched and to be manufactured and marketed in India, Rule 23 sets 30 working days.
Is CTRI registration mandatory for neurology trials?
Yes. Rule 25 requires every clinical trial to be registered on the Clinical Trials Registry – India, maintained by ICMR, before the first participant is enrolled.
Resource Spotlight
Exploring other areas? See our cardiovascular clinical trials, obesity and diabetes trials and full range of clinical trial services in India.
Start Your Neurology or Psychiatry Trial in India
Planning a CNS study? Share your protocol synopsis for a feasibility and budget estimate.
Running a global trial? We can add Indian sites and manage them locally.
+91 98968 89927 · info@shenclinicalservices.com · A 302, Urban Square, Sector-62, Gurugram, Haryana 122098
Sources: ICMR and partners, burden of neurological disorders across India (Lancet Global Health, 2021); Lok Sabha reply on the National Mental Health Survey; Dementia prevalence in India (Alzheimer’s & Dementia, 2023); New Drugs and Clinical Trials Rules, 2019 (CDSCO); Clinical Trials Registry – India. General regulatory information, not legal advice.