CTRI

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CTRI Number

CTRI/2025/08/093625 [Registered on: 25/08/2025] Trial Registered Prospectively

Last Modified On:

21/08/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Medical Device
Diagnostic
Screening

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

A study to compare the effectiveness of Quetiapine and Trazodone for treating patients with sleep disturbance associated with Alcohol Dependence

Scientific Title of Study

Randomized Comparison Trial between low dose Quetiapine and Trazodone for treatment of Short- Term Insomnia in patients with Alcohol Dependence in Early Full Remission

Trial Acronym

Nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Hemasri Rajendiran
Designation	Postgraduate Resident
Affiliation	Mahatma Gandhi Medical College , Sri balaji vidyapeeth
Address	Department of Psychiatry , Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillaiyarkuppam, Pondicherry - 607402 India. Pondicherry PONDICHERRY 607402 India
Phone	7899240008
Fax
Email	hemasri.rajk@gmail.com

Details of Contact Person
Scientific Query

Name	Dr.Avudaiappan S
Designation	Professor
Affiliation	Mahatma Gandhi Medical College , Sri balaji vidyapeeth
Address	Department of Psychiatry , Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillaiyarkuppam, Pondicherry - 607402 India. Department of Psychiatry , Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillaiyarkuppam, Pondicherry - 607402 India. Pondicherry PONDICHERRY 607402 India
Phone	94861122540
Fax
Email	dravudai@gmail.com

Details of Contact Person
Public Query

Name	Hemasri Rajendiran
Designation	Postgraduate Resident
Affiliation	Mahatma Gandhi Medical College , Sri balaji vidyapeeth
Address	Department of Psychiatry , Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillaiyarkuppam, Pondicherry - 607402 India. Pondicherry PONDICHERRY 607402 India
Phone	7899240008
Fax
Email	hemasri.rajk@gmail.com

Source of Monetary or Material Support

Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth

Primary Sponsor

Name	Mahatma Gandhi Medical College and Research Institute, Sri Balaji Vidyapeeth
Address	Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus, Pillaiyarkuppam, Pondicherry - 607402 India
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrHemasri Rajendiran	Mahatma Gandhi Medical College and Research Institute	Inpatient and outpatient services, Department of Psychiatry, Mahatma Gandhi Medical College and Research Institute, SBV Pondicherry Campus,Pillaiyarkuppam , Pondicherry - 607402, India Pondicherry PONDICHERRY	07899240008 hemasri.rajk@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: F102\|\|Alcohol dependence,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Quetiapine	12.5 to 100 mg OD, Oral for 8 weeks
Comparator Agent	Trazodone	25 to 50 mg OD, Oral for 8 weeks

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	1. Patients aged between 18 and 65 years 2. Patients diagnosed with alcohol dependence, in early full remission with short term insomnia. 3. Patients having moderate to severe insomnia as per Insomnia Severity Index scale 4. Patients giving consent for overnight type 1 polysomnography.

ExclusionCriteria

Details

1. Preexisting comorbid, psychotic disorders, mood disorders, anxiety disorders or
dementia
2. History of any other street drugs, non-prescribed tranquilizers or, psychotropic drugs
within 2 weeks before the pre-inclusion visit (anxiolytics, hypnotics, antidepressants, neuroleptics, carbamazepine, b-blocking agents (except if ,prescribed before alcohol detoxification), clonidine, antihistamines (if necessary, they were permitted for at most 5 consecutive days), narcotic analgesics,
amphetamines, and related substances.
3. Other comorbid substance use disorders, except Nicotine
4. Contraindications or intolerance to either Quetiapine or Trazodone
5. History of seizure disorder, intellectual disability, or significant head injury.

Method of Generating Random Sequence

Permuted block randomization, fixed

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
1. To compare the change in objective sleep efficiency measured by Type 1 polysomnography from baseline to week 8 between the Quetiapine and Trazodone groups diagnosed with Alcohol Dependence Syndrome in early full remission	1 year

Secondary Outcome

Outcome

TimePoints

1. To compare the change in subjective sleep quality between the two groups, as
measured by the Pittsburgh Sleep Quality Index (PSQI).
2. To compare the severity of insomnia by Insomnia severity index (ISI) score
3. To compare the severity of craving by Penn Alcohol craving scale (PACS)
4. To compare the severity of mood / Anxiety symptoms by Hospital Anxiety and
Depression scale (HADS)
5. To evaluate & compare the safety & tolerability of Quetiapine & Trazodone
using a self-designed questionnaire for FDA listed Adverse events

Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks & 8 weeks

Target Sample Size

Total Sample Size="56"
Sample Size from India="56"
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

Phase 4

Date of First Enrollment (India)

01/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

01/09/2025

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

This is a single-centre, randomized, open label , parallel-group trial comparing the effectiveness of Quetiapine (initial dose 12.5 mg, titrated up to 100 mg/day) and Trazodone (initial dose 25 mg, titrated up to 50 mg/day) in the management of short-term insomnia among individuals with alcohol use disorder in early full remission. Patients diagnosed with Alcohol Dependence, in early full remission presenting with short term Insomnia attending Outpatient (OP) / Inpatient (IP) services in the department of psychiatry, Mahatma Gandhi Medical College and Research Institute, Puducherry. The primary outcome will compare the change in objective sleep efficiency measured by Type 1 polysomnography from baseline to week 8 between the Quetiapine and Trazodone groups. The secondary outcome will compare the change in subjective sleep quality between the two groups, as measured by the Pittsburgh Sleep Quality Index (PSQI), severity of insomnia by Insomnia severity index (ISI) score, severity of craving by Penn Alcohol craving scale (PACS), severity of mood / Anxiety symptoms by Hospital Anxiety and Depression scale (HADS), compare the safety and tolerability of Quetiapine and Trazodone using a self-designed questionnaire for FDA listed Adverse events weekly for a total study duration of 8 weeks for each participant.