Amitriptyline and Paroxetine Treatment of Major Depression

Verified by: Central Institute of Mental Health, Mannheim, December 2009
First Received: January 12, 2010 | Last Updated: January 13, 2010 | Phase: Phase 3 | Start Date: October 1997
Overall Status: Completed | Estimated Enrollment: 127
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: May 2000

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: amitriptyline
  • Active Comparator: paroxetine

Outcome Measures for this Clinical Trial

Primary Measures

  • Hamilton Depression Rating Scale (21-item version)
    • Time Frame: baseline, weekly assessments for 5 weeks
      Safety Issue?: No

Secondary Measures

  • 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)
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • age: above 18
  • depression according DSM-IV

Exclusion Criteria:

  • bipolar disorder
  • substance dependency

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Central Institute of Mental Health, Mannheim Other

Overall Clinical Trial Officials and Contacts

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

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01049347

Study ID Number: AmiPar

ClinicalTrials.gov Identifier: NCT01049347

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01049347