NCT01049347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 1997

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2000

Completed
9.7 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2010

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

2.6 years

First QC Date

January 12, 2010

Last Update Submit

January 30, 2024

Conditions

Unipolar Depression

Keywords

depression

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (21-item version)

    baseline, weekly assessments for 5 weeks

Secondary Outcomes (1)

  • 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)

Study Arms (2)

amitriptyline

ACTIVE COMPARATOR
Drug: amitriptyline

paroxetine

ACTIVE COMPARATOR
Drug: paroxetine

Interventions

amitriptylineDRUG

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

amitriptyline
paroxetineDRUG

40 mg oral, single dose, morning, 35 days

paroxetine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age: above 18
  • depression according DSM-IV

You may not qualify if:

  • bipolar disorder
  • substance dependency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Institute of Mental Health

Mannheim, 68159, Germany

Location

Related Publications (2)

  • 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.

    PMID: 23277262DERIVED

  • 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.

    PMID: 20952454DERIVED

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

AmitriptylineParoxetine

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

DibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Michael Deuschle, MD

    Central Institute of Mental Health, Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 14, 2010

Study Start

October 1, 1997

Primary Completion

May 1, 2000

Study Completion

May 1, 2000

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

DE(1)