| CTRI Number |
CTRI/2025/08/092417 [Registered on: 05/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Tofisopam and Clonazepam in Reducing Anxiety Symptoms in Adults with Generalized Anxiety Disorder |
|
Scientific Title of Study
|
A comparison of the anxiolytic properties of Tofisopam and Clonazepam—A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 40/04.04.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kurma Ramya Krishna |
| Designation |
Assistant professor |
| Affiliation |
Konaseema Institute of Medical Sciences and Reseach foundation |
| Address |
Department of Psychiatry, Room no. 2, Old Block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr B. R. Ambedkar Konaseema District.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
08332885221 |
| Fax |
|
| Email |
ramyakrishna251@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kurma Ramya Krishna |
| Designation |
Assistant professor |
| Affiliation |
Konaseema Institute of Medical Sciences and Reseach foundation |
| Address |
Department of Psychiatry, Room no. 2, Old Block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
08332885221 |
| Fax |
|
| Email |
ramyakrishna251@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kurma Ramya Krishna |
| Designation |
Assistant professor |
| Affiliation |
Konaseema Institute of Medical Sciences and Reseach foundation |
| Address |
Department of Psychiatry, Room no. 2, Old Block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.
East Godavari
ANDHRA PRADESH
533201
India |
| Phone |
08332885221 |
| Fax |
|
| Email |
ramyakrishna251@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kurma Ramya Krishna |
| Address |
Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Kurma Ramya Krishna |
Konaseema Institute of Medical sciences and Research foundation |
Department of Psychiatry, Room no. 2, Old Block, Konaseema Institute of Medical Sciences and Research Foundation, Chaitanya Health City, NH 214, Amalapuram, Dr. B. R. Ambedkar Konaseema District.
East Godavari
ANDHRA PRADESH |
08332885221
ramyakrishna251@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F410||Panic disorder [episodic paroxysmal anxiety], (3) ICD-10 Condition: F401||Social phobias, (4) ICD-10 Condition: F400||Agoraphobia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clonazepam |
It will be started along with escitalopram at a dose of 0.25 mg twice daily. Based on the response and clinical improvement, the dose may be increased to a maximum of 2 mg per day. |
| Intervention |
Tofisopam |
It will be started along with escitalopram at a dose of 50 mg once daily. Based on the response and clinical improvement, it may be increased to a maximum dose of 200 mg per day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are diagnosed with any anxiety disorder according to the International Classification of Diseases (ICD-11). This includes the diagnosis of phobias, panic disorders, and generalized anxiety disorder.
2. Past diagnosis of mental illness, but not on medication for at least 3 months.
|
|
| ExclusionCriteria |
| Details |
1. Organic causes for the anxiety symptoms.
2. Presence of uncontrolled medical conditions such as hypertension, diabetes mellitus, bronchial asthma, etc.
3. Presence of severe medical conditions that might interfere with assessment, such as cancer, renal problems, cardiac problems, etc.
4. Pregnancy
5. Unwilling to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in scores of the Hamilton Anxiety Rating Scale |
Changes in scores of the Hamilton Anxiety Rating Scale at baseline, 2 weeks, and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the tolerability between the two anxiolytics by a generic assessment of the Side Effects scale. |
Baseline, 2 weeks, and 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Anxiety acts as an alerting signal. It is characterized by a diffuse, unpleasant, and vague sense of apprehension, often accompanied by autonomic symptoms such as headache, perspiration, palpitations, chest tightness, stomach discomfort, and restlessness. These symptoms tend to vary among persons. Anxiety disorders are among the most prevalent psychiatric conditions. It is also the leading cause of distress and impairment. This group includes clinically related but distinct mental disorders. It includes panic disorder, phobias, social anxiety disorder, and generalized anxiety disorder. Clonazepam and etizolam are established as anxiolytic agents. Tofisopam was approved over 35 years ago and was recently launched in India. It is efficacious compared to other benzodiazepines in treating anxiety disorders. It was found to have significant anxiolytic effects with no impairment of attention or somnolence and was well tolerated with no adverse effects. The clinical effect of tofisopam is evident as early as 1 week, with a maximum response by 3 weeks, at a dose of 150 to 300 mg/day. This would prove to be a game-changer in the treatment of anxiety disorders. Data exists on the clinical effectiveness of Tofisopam in anxiety disorders, but there is a lack of research on the direct comparison of Tofisopam with other established benzodiazepines in patients with anxiety disorders. We intend to explore this aspect and find out whether, in comparison with Clonazepam, Tofisopam is effective and has a better side effect profile. This can have more clinical implications for the use of tofisopam clinically. |