Major depression Mental and Behavioural Disorders Depressive episode
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patient group: 1.1. Patients suffering from a current major depressive episode, single episode or recurrent, diagnosed according to Diagnostic and Statistical Manual for Mental Disorders Criteria 1.2. A 17-item Hamilton Depression Rating Scale (HDRS) total score of 18 or higher. 1.3. Aged between 18 and 65 years 2. Control group: 2.1. Healthy subjects with no history of chronic physical illness, substance abuse or mental diseases and not taking regular medications in the last month were recruited 2.2. Free of chronic and acute physical illness within the 2 weeks before the study 2.3. Aged between 18 and 65 years 3. Written information was given and written informed consent was obtained from each patient to participate
Exclusion criteria
Exclusion criteria: 1. Patient group: 1.1. Presence of other major axis I disorders, including schizophrenia, bipolar disorders, anxiety disorders, substance-related disorders and eating disorders 1.2. Presence of any acute physical disorders and/or exposure to any psychotropic drugs in the last month 2. Control group 2.1. History of chronic physical illness, substance abuse or mental diseases or taking regular medications in the last month 2.2. Free of chronic and acute physical illness within the 2 weeks before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BDNF levels in platelets and plasma, measured at baseline, 8 and 24 weeks of treatment in the patient group, once in the control group | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of depression was assessed using the 17-item Hamilton Depression Rating Scale (HDRS) 2. Cognitive performance, assessed by: 2.1. Wechsler Adult Intelligence Scale (WAIS-III): Vocabulary, Buckets of Kohs, numerical key similitudes 2.2. Wechsler Memory Scale (WMS-III): Digits, Verbal Memory I, Verbal Memory II 2.3. Train Making Test (TMT) part A and B 2.4. Auditory Verbal Learning Test (AVLT de Rey) (Rey 1964) 2.5. Stroop Color and Word Test 2.6. Wisconsin Card Sorting Test (WCST) 3. Quality of life scales: 3.1. Social Adaptation Self-evaluation Scalen (SASS) 3.2. Perceived Stress Scale (PSS) 3.3. Quality of Life in Depression Scale (QLDS) 4. Personality, assessed by Eysenck Personality Questionnaire (EPQ) Clinical assessments were conducted at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks of treatment, once in the control group. | — |
Countries
Spain