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The syndrome of altered sensations like pain, tingling, burning or numbness on one side of the body, and its response to antidepressants drugs: A trial in which one group of patients receives one drug and another group another antidepressant drug, after randomization.

Hemi sensory pain syndrome and its response to antidepressants: A randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080082
Enrollment
216
Registered
2025-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders

Interventions

Intervention1: 2 Drugs 1 Drug to each group (after randomization): Tablet Amitriptyline 10mg (Tricyclic antidepressant) Tablet Escitalopram 10mg (Selective Serotonin Reuptake inhibitor) Intervention2

Sponsors

Medanta The Medicity
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients with a normal brain imaging, complaining of spontaneous onset symptoms affecting one side of the body including head and both limbs. Complaints could include increased sensory symptoms, described as tingling (or pins and needles), pricking, tightening or burning. This may also be described as paresthesia or dysesthesia. There should be no evidence of suicidal ideation Patient should have the ability to complete questionnaires, trial assessments, and provide written informed consent.

Exclusion criteria

Exclusion criteria: 1) Bilateral sensory symptoms 2) Concomitant focal neurological symptoms and signs such as diplopia, dysarthria, dysphagia, focal weakness or ataxia. 3) Abnormal MRI brain 4) Patients with past history of complex regional pain syndrome (CRPS), chronic pain syndrome 5)Pregnant, breastfeeding, or planning to become pregnant; 6)Current use of, or allergy or contraindications to, a tricyclic antidepressant 7) Current use of monoamine oxidase (MAO) inhibitors 8) On allergy medications (diphenhydramine, loratadine, fexofenadine, chlorpheniramine or cetirizine); cimetidine 9)Patients who have or have ever had glaucoma 10) History of seizures or seizure disorder 11) Cardiac diseases- arrhythmias, QTc (corrected QT) prolongation, recent myocardial infarction, or heart failure

Design outcomes

Primary

MeasureTime frame
1. VAS scale for scoring pain 2. Migraine disability assessment 3. Depression and anxiety assessment Timepoint: Baseline, on first contact with investigator After 4 weeks

Secondary

MeasureTime frame
1) To test the effectiveness of Amitriptyline 10mg (tricyclic antidepressant) and Escitalopram 10mg (selective serotonin reuptake inhibitor) on the relief of hemi sensory pain syndrome. 2) To find out adverse effects of Amitriptyline and Escitalopram. Timepoint: After 4 weeks At any point, in case of adverse effect

Countries

India

Contacts

Public ContactDr Rinku Moni Gogoi

Institute of Neurosciences, Medanta-The Medicity, Gurugram

drvinaygoyal@gmail.com9810470250

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026