Depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
All patients gave a complete medical and psychiatric history and were given a physical examination before entry into the study. Then 19 subjects were assigned in a random fashion to nortriptyline 50 m
Sponsors
Tehran University of Medical Sciences (Iran)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: After giving informed consent and discontinuing all psychotropic medications for 2 weeks, 45 outpatients (28 female and 17 male) between 18 and 54 years of age were enrolled in the study. Seven subjects dropped out after the first week of treatment due to noncompliance (3 subjects from group 1 and 4 subjects from group 2) leaving 38 patients (24 female and 14 male) who completed the trial. All subjects met the Diagnostic and Statistical Manual of Mental Disorders, Fourth edition (DSM-IV) criteria for major depressive disorder (MDD), based on the structured clinical interview for DSM-IV and had a baseline Hamilton Rating scale for depression (HAM-D, 17 item) score of at least 20. The HAM-D is, the most widely used physician-administrated rating scale for depression, summates 17 individual item scores to provide a total score indicative of the severity of depression.
Exclusion criteria
Exclusion criteria: Patients with a history of other psychiatric disorders, history of bipolar disorder, personality disorder, anxiety disorder, substance abuse, alcoholism, and organic brain disorders were excluded. Also patients were excluded if they were psychotic or posed a significant risk of suicide at any time during participation. Pregnant or lactating women were excluded. All patients were free of unstable medical disorders including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or hematological illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The principal measure of the outcome was the 17-item HAM-D. The mean decrease in HAM-D score from baseline was used as the main outcome measure of response of depression to treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side-effects were systematically recorded throughout the study and were assessed using a checklist administered by a resident of psychiatry on week 2, 4, 6 and 8. | — |
Countries
Iran
Outcome results
None listed