Amitriptyline and Paroxetine Treatment of Major Depression

January 30, 2024 updated by: Central Institute of Mental Health, Mannheim

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68159
        • Central Institute of Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age: above 18
  • depression according DSM-IV

Exclusion Criteria:

  • bipolar disorder
  • substance dependency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: paroxetine
Drug: paroxetine
40 mg oral, single dose, morning, 35 days
Active Comparator: amitriptyline
Drug: amitriptyline
150 mg oral, daily, single evening dose, 35 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hamilton Depression Rating Scale (21-item version)
Time Frame: baseline, weekly assessments for 5 weeks
baseline, weekly assessments for 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Institute of Mental Health, Mannheim

Investigators

  • Principal Investigator: Michael Deuschle, MD, Central Institute of Mental Health, Mannheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 1997

Primary Completion (Actual)

May 1, 2000

Study Completion (Actual)

May 1, 2000

Study Registration Dates

First Submitted

January 12, 2010

First Submitted That Met QC Criteria

January 13, 2010

First Posted (Estimated)

January 14, 2010

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AmiPar
  • DFG De 660/1-1 (Other Grant/Funding Number: German Research Council)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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