Effects of trazodone and melatonin on sleep in depressed patients receiving sertraline

Comparing effects of 8-week treatment with melatonin versus trazodone on sleep quality in patients with major depressive disorder who are on sertraline

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201411297202N9

Enrollment

Registered

2017-05-22

Start date

2014-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Major depressive disorder. Severe depressive episode without psychotic symptoms

Interventions

Intervention 1: Sertraline, starting with 25 mg daily and increase dose to 150 mg daily over 3 weeks and continuing treatment for 3 more weeks- total time of treatment 2 months and Melatonin, tablet 3

Treatment - Drugs

Sertraline, starting with 25 mg daily and increase dose to 150 mg daily over 3 weeks and continuing treatment for 3 more weeks- total time of treatment 2 months and Melatonin, tablet 3 mg orally, onc

Sertraline, tablet 150 mg orally, once daily for 2 months and Trazodone, tablet 50 mg orally, once at bedtime for 2 months

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Age range 18-65; No use of antidepressants for at least one month prior to the study; At least five basic literacy to fill out the questionnaire Beck Exclusion criteria: pregnancy; lactation; A history of drug in the last six months; Serious physical illnesses such as cancer, cardiovascular diseases, respiratory, cerebrovascular diseases and disorders of the thyroid (Hypo or hyperthyroidism); People with other axis I psychiatric disorders and mental retardation; Working the night shift in a month 7)Use of other drugs affecting sleep (corticosteroids, etc.)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sleep quality. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Pittsburgh Questionnaire.	—

Secondary

Measure	Time frame
Depression. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Hamilton Depression Scale.;Depression. Timepoint: At baseline, 1 month after the baseline and 2 months after baseline. Method of measurement: Beck Depression scale.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Padideh Ghaeli

Tehran University of Medical Sciences

pghaeli@sina.tums.ac.ir00

Outcome results

None listed

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