Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
127
150 mg oral, daily, single evening dose, 35 days
40 mg oral, single dose, morning, 35 days
Central Institute of Mental Health
Mannheim, Germany
Hamilton Depression Rating Scale (21-item version)
Time frame: baseline, weekly assessments for 5 weeks
cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment
Time frame: daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)
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