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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/093625

Enrollment

Registered

2025-08-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: F102- Alcohol dependence

Interventions

Intervention1: Quetiapine: 12.5 to 100 mg OD, Oral for 8 weeks Control Intervention1: Trazodone: 25 to 50 mg OD, Oral for 8 weeks

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
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 remissionTimepoint: 1 year	—

Secondary

Measure	Time frame
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 eventsTimepoint: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks & 8 weeks	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactHemasri Rajendiran

Mahatma Gandhi Medical College , Sri balaji vidyapeeth

dravudai@gmail.com94861122540

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026