An Open-label, Single-arm, Prospective, Multicenter Study to Evaluate Safety and Efficacy of Zolsoma Tablets in Patients with Insomnia

Aim:-   To evaluate safety and efficacy of Zolsoma tablet

Primary objective:

-  To document any adverse events associated with the use of Zolsoma tablets

-  To evaluate day time sleep using Epworth Sleepiness scale.

Secondary objective:

-    Measurement of quality of sleep and sleep latency using Pittsburgh Sleep Quality Index

-   To determine the changes in severity of insomnia by using Insomnia severity Index.

Study Site:

Out-patient departments of Psychiatry of Asha Hospitals, Banjara Hills, Hyderabad, Telangana.,

of LTMMC and LTMGH, Sion, Mumbai.,

of Poona Hospital & Research centre , Pune.,

of Vardhman Mahavir Medical College & Safdarjung Hospital, New Delhi

 **Duration of Study:**The maximum study duration for a patient is 45 days (Screening to Follow-up Visit).

Study Description:

Design:  Prospective, multi-centre, open label, single-arm

Sample Size: Two Hundred and Eighty (280) patients will be recruited in the study

Sample Method: All patients fulfilling inclusion criteria will be included in the study

Study Population:

·       Inclusion Criteria:

1.    Patients of either gender of age 18 years and above

2.      Patients visiting Psychiatry opd with complaints of comorbid disorders

3.      A history of daytime complaints associated with disturbed sleep.

4.    Patients are required to have language competency to respond to study related questionnaires including Pittsburgh Sleep Quality Index, Insomnia Severity Index and Epworth Sleepiness Scale to measure the quality of sleep and sleep latency.

5.      Patients with self-reported sleep disturbances.

6.      Patients with normal medical history and a record of Physical Examination, Lab Tests are included.

7.      Women of childbearing potential are required to receive a highly effective form of contraception.

8.      Subjects willing to sign the Informed Consent Form Subject or legally acceptable representative (LAR) is able to attend all scheduled visits and to comply with the trial protocol.

Exclusion criteria:

1.      Patients who have consumed any sedative (Benzodiazepine/ Baribiturate) one week prior to the initiation of the study.

2.      Subjects with history of substance abuse except nicotine use.

3.      Patients with known hypersensitivity or any contraindications to the use of any study medication.

4.      Patients with chronic illness that might interfere with the trial completion or conduct.

5.      Pregnant women & lactating mothers & women intending pregnancy.

6.      Subject who is identified as a natural or adopted child of the investigator, relatives or employee with direct involvement in the proposed study.

STUDY ENDPOINTS

Efficacy EndpointsPrimary Endpoint

Change from Screening/ Baseline in Pittsburgh Insomnia rating scale at Day 30±2 [Time Frame: Baseline and Day 30±2]

                       Secondary Endpoint

Change from Screening/ Baseline in Insomnia Severity Index (ISI) at Day 30±2 [Time Frame: Baseline and Day 30±2]

Safety Endpoints

Primary Endpoint

Safety/ Tolerability: Number of Participants with Adverse Events (AEs) [Time Frame: From enrollment up to Day 30± 2]

Secondary Endpoint

Change from Screening/ Baseline in Epworth Sleepiness Scale at Day 30±2 [Time Frame: Baseline and Day 30±2]

Study Procedure:

Screening /Washout Period (Visit 1 – Within 3 days prior to Treatment Initiation)

Baseline Phase :     Visit 2 - Day 1 – Treatment Initiation

Follow –up Visit-1 :  Visit 3/ week 1- Day 7 ± 2

End of treatment :    Visit 4/week 5- Day  30±2

Follow-up Period

On completion of the treatment period, a follow up visit will be performed either in person or telephonically to inquire the overall well-being of the patient. The patients will be followed-up for a period of up to 7 days from the end of treatment visit.

**Rescue Medication :**Any rescue medication which is taken by the patient should be recorded in the daily diary.

**Statistical Methodology :**The analyses in the ITT population will be considered primary and those on the PP population as supportive.

All continuous safety and demographic variables will be calculated using descriptive statistics n, mean, median and range.