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Amitriptyline and Paroxetine Treatment of Major Depression

Primary Purpose

Unipolar Depression

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
amitriptyline
paroxetine
Sponsored by
Central Institute of Mental Health, Mannheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unipolar Depression focused on measuring depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age: above 18
  • depression according DSM-IV

Exclusion Criteria:

  • bipolar disorder
  • substance dependency

Sites / Locations

  • Central Institute of Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

amitriptyline

paroxetine

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (21-item version)

Secondary Outcome Measures

cortisol in saliva (8.00, 16.00, 22.00) during wash-out (6 days) and 35 days of treatment

Full Information

First Posted
January 12, 2010
Last Updated
January 13, 2010
Sponsor
Central Institute of Mental Health, Mannheim
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1. Study Identification

Unique Protocol Identification Number
NCT01049347
Brief Title
Amitriptyline and Paroxetine Treatment of Major Depression
Official Title
Hypothalamus-pituitary-adrenal System: Role of the Mineralocorticoid Receptor and Longitudinal Study in Depressed Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 1997 (undefined)
Primary Completion Date
May 2000 (Actual)
Study Completion Date
May 2000 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Central Institute of Mental Health, Mannheim

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
amitriptyline
Arm Type
Active Comparator
Arm Title
paroxetine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
amitriptyline
Intervention Description
150 mg oral, daily, single evening dose, 35 days
Intervention Type
Drug
Intervention Name(s)
paroxetine
Intervention Description
40 mg oral, single dose, morning, 35 days
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (21-item version)
Time Frame
baseline, weekly assessments for 5 weeks
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age: above 18 depression according DSM-IV Exclusion Criteria: bipolar disorder substance dependency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Deuschle, MD
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Institute of Mental Health
City
Mannheim
ZIP/Postal Code
68159
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23277262
Citation
Schilling C, Gilles M, Blum WF, Daseking E, Colla M, Weber-Hamann B, Lederbogen F, Krumm B, Heuser I, Wudy SA, Kopf D, Deuschle M. Leptin plasma concentrations increase during antidepressant treatment with amitriptyline and mirtazapine, but not paroxetine and venlafaxine: leptin resistance mediated by antihistaminergic activity? J Clin Psychopharmacol. 2013 Feb;33(1):99-103. doi: 10.1097/JCP.0b013e31827cb179.
Results Reference
derived
PubMed Identifier
20952454
Citation
Paslakis G, Kopf D, Westphal S, Gilles M, Lederbogen F, Hamann B, Heuser I, Deuschle M. Treatment with paroxetine, but not amitriptyline, lowers levels of lipoprotein(a) in patients with major depression. J Psychopharmacol. 2011 Oct;25(10):1344-6. doi: 10.1177/0269881110382469. Epub 2010 Oct 15.
Results Reference
derived

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Amitriptyline and Paroxetine Treatment of Major Depression

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