| CTRI Number |
CTRI/2020/12/029734 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study to Evaluate the Effectiveness and Safety of Zolpidem Tartrate Combined
with Cognitive Behavioral Therapy Versus Cognitive Behavioral Therapy Alone in Patients with Insomnia Associated with Comorbid Anxiety. |
|
Scientific Title of Study
|
A Prospective, pilot, randomized, single-center, clinical study to evaluate the
effectiveness and safety of Zolpidem Tartrate combined with cognitive behavioral therapy
verses cognitive behavioral therapy alone in patients with insomnia associated with comorbid
anxiety. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZOLTD004-01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahesh Gowda |
| Designation |
Senior Consultant Psychiatrist |
| Affiliation |
Spandana Nursing Home |
| Address |
Department Psychiatry
Spandana Nursing Home
549/46, 6thMain, 4thBlock, Rajajinagar Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9845134915 |
| Fax |
|
| Email |
maheshrgowda@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Gowda |
| Designation |
Senior Consultant Psychiatrist |
| Affiliation |
Spandana Nursing Home |
| Address |
Department Psychiatry
Spandana Nursing Home
549/46, 6thMain, 4thBlock, Rajajinagar Bangalore
Bangalore
KARNATAKA
560010
India |
| Phone |
9845134915 |
| Fax |
|
| Email |
maheshrgowda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vairamuthu Ammaiyappan |
| Designation |
Associate Director Project Management |
| Affiliation |
iDD Research Solutions Pvt Ltd |
| Address |
Department Clinical Operation & Project Management, 4th Floor, Ektha Serene, located at 103/H | GB & 104 / HIG-B Survey, No 132, APHB Colony, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
9986604998 |
| Fax |
|
| Email |
vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Dr. Mahesh Gowda
Senior Consultant Psychiatrist
Spandana Nursing Home |
|
|
Primary Sponsor
|
| Name |
Dr Mahesh Gowda |
| Address |
Department Psychiatry Spandana Nursing Home 549/46, 6thMain, 4thBlock, Rajajinagar Bangalore - 560010, Karnataka |
| 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 |
| Dr Mahesh Gowda |
Spandana Nursing Home |
Department Psychiatry
549/46, 6thMain, 4thBlock, Rajajinagar
Bangalore
KARNATAKA |
9845134915
maheshrgowda@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Zolpidem Tartrate (Zolfesh) 10 mg |
Zolpidem Tartrate Tablet (Zolfesh) 10mg is taken orally with water daily immediately before bedtime with at least 7-8 hours remaining before the planned time of awakening for total 8 weeks at home. |
| Comparator Agent |
Cognitive-Behavior Therapy |
Cognitive-Behavior Therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients above 18 years of age.
2. Patients with HAM A score of at least 18) with known history of insomnia (ISI ≥7) not on pharmacotherapy
3. Patients on psychotropics, after a washout period equivalent to four half-lives of the drug 4. The patient has read the informed consent form, has understood the relevant aspects of the clinical study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure
5. Patients willing to fill patient diaries, have good compliance, and willing to comply with the study procedure and requirements
6. Patients with no mental disease and are not using psychoactive medications
7. Both male and female (of childbearing potential) patients willing to use appropriate method of contraception as per investigator’s discretion, throughout the study. Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit. |
|
| ExclusionCriteria |
| Details |
1. Patients with sleep disorder such as narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome or obstructive sleep apnea syndrome or with severe, life-threatening chronic sleep disorders, hepatic failure, thyroid dysfunction, cardiovascular diseases, myasthenia gravis, respiratory insufficiency, anaphylaxis and angioedema
2. Patients with severe psychiatric disorder or a history of major psychiatric disorder (e.g. depression, autism, suicide attempt, bipolar disorder, schizophrenia etc.) or psychomotor impairment
3. Patients taking sleep medications, psychotherapy or acupuncture for insomnia within a month prior to enrolment into the study
4. Patients with a history of drug addiction, drug or alcohol abuse or likely to concomitantly consume alcoholic beverages more than 3 times/week
5. Patients with a progressive medical illness (e.g., cancer, dementia) directly related to the onset and course of insomnia
6. Patients who take medications known to alter sleep (e.g., Alpha-blockers, Betablockers, Corticosteroids, SSRI antidepressants, ACE inhibitors, ARBs Cholinesterase inhibitors, Histamine 1 antagonists, Glucosamine/chondroitin, and Statins)
7. Patients with an evidence of sleep-disordered breathing or sleep-related movement disorder
8. Patients with nightshift work or irregular sleep schedule
9. Patients participated in any investigational drug trial within 4 weeks prior to enrolment into the study
10. Patients with hypersensitivity to zolpidem tartrate or any of the inactive ingredients
11. Patients who are not willing to follow study procedures and have poor treatment compliance 12. Chronic user of benzodiazepines as this may cause tolerance to zolpidem
13. Patients with any other conditions or diseases that investigator considers it as inappropriate to enter the study as per prescribing information.
14. Female patients who are pregnant, lactating or intend to become pregnant during the study period |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the effectiveness of zolpidem tartrate combined with cognitive behavioral therapy (CBT) versus CBT alone in terms of reduction in Insomnia Severity Index (ISI) total score from baseline to follow up visit and End of study visit in patients with insomnia associated with comorbid anxiety. |
At baseline visit(Day 0),week-4 and week-8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the improvement in symptoms of anxiety from baseline to follow up visit and End of study visit in group A versus group B
2. To assess health-related quality of life (HRQOL) from baseline to follow up visit and End of study visit in group A versus group B
3. To evaluate the safety and tolerability of zolpidem tartrate in patients with insomnia associated with comorbid anxiety |
1. Baseline visit(day 0),week-4 and week-8
2. Baseline visit(day 0),week-4 and week-8
3. Baseline visit(day 0),week-4 and week-8 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
10/02/2021 |
| Date of Study Completion (India) |
14/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Insomnia is a disturbance of normal sleep patterns commonly characterized by difficulty in initiating sleep (sleep onset insomnia) and/or difficulty in maintaining sleep (sleep maintenance) and imposes a significant negative impact on patient’s quality of life(QOL). Insomnia is prevalent public health problem affecting large number of population all over the world on a situational, recurrent, or chronic basis. Despite its high prevalence, morbidity, and costs, insomnia often remains untreated; when treatment is initiated, it is often limited to self-help remedies (e.g., alcohol, over-the-counter drugs) of questionable efficacy and safety. Patients with insomnia generally have subsyndromal levels of physiological symptoms of anxiety, including tachycardia, trembling, sweating, dizziness, gastrointestinal distress. There is a symptomatic overlap between insomnia and anxiety, including agitation, irritability, loss of appetite, muscle tension and poor concentration. Hence, treatment of insomnia may reduce the levels of anxiety and increase patient QOL. In the current investigator initiated study, we plan to evaluate the effectiveness and safety of the combination of CBT and Zolpidem Tartrate (a nonbenzodiazepine hypnotic indicated for short term treatment of insomnia) against CBT alone in patients with insomnia associated with comorbid anxiety. |