Amitriptyline and Paroxetine Treatment of Major Depression

Phase 3

Completed

• Conditions: Unipolar Depression
• Interventions: Drug: amitriptyline; Drug: paroxetine

• Registration Number: NCT01049347
• Lead Sponsor: Central Institute of Mental Health, Mannheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-10
• Primary Completion: 2000-05
• Study Completion: 2000-05
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-13
• Study First Posted: 2010-01-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

• age: above 18
• depression according DSM-IV

Exclusion Criteria

• bipolar disorder
• substance dependency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amitriptyline	amitriptyline	-
paroxetine	paroxetine	-

Primary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (21-item version)	baseline, weekly assessments for 5 weeks

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Central Institute of Mental Health; 🇩🇪 Mannheim, Germany