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Amitriptyline and Paroxetine Treatment of Major Depression

NCT01049347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-01-31

No results posted yet for this study

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.

Conditions

  • Unipolar Depression

Interventions

DRUG

amitriptyline

150 mg oral, daily, single evening dose, 35 days

DRUG

paroxetine

40 mg oral, single dose, morning, 35 days

Sponsors & Collaborators

  • Central Institute of Mental Health, Mannheim

    lead OTHER

Principal Investigators

  • Michael Deuschle, MD · Central Institute of Mental Health, Mannheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-10-31
Primary Completion
2000-05-31
Completion
2000-05-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01049347 on ClinicalTrials.gov