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NCT01049347 Clinical Trial

Amitriptyline and Paroxetine Treatment of Major Depression

Unipolar Depression Clinical Trial

Official title:
Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01049347
Other study ID # AmiPar
Secondary ID DFG De 660/1-1
Status Completed
Phase Phase 3
First received
Last updated
Start date October 1997
Est. completion date May 2000

Study information
Verified date January 2024
Source Central Institute of Mental Health, Mannheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 127
Est. completion date May 2000
Est. primary completion date May 2000
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age: above 18 - depression according DSM-IV Exclusion Criteria: - bipolar disorder - substance dependency

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• amitriptyline
150 mg oral, daily, single evening dose, 35 days
• paroxetine
40 mg oral, single dose, morning, 35 days

Locations
Country Name City State
Germany Central Institute of Mental Health Mannheim

Sponsors (1)
Lead Sponsor Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hamilton Depression Rating Scale (21-item version) baseline, weekly assessments for 5 weeks
Secondary cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)
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