Amitriptyline and Paroxetine Treatment of Major Depression

NCT ID: NCT01049347

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2000-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Unipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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amitriptyline

Group Type ACTIVE_COMPARATOR

amitriptyline

Intervention Type DRUG

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

paroxetine

Group Type ACTIVE_COMPARATOR

paroxetine

Intervention Type DRUG

40 mg oral, single dose, morning, 35 days

Interventions

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amitriptyline

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

Intervention Type DRUG

paroxetine

40 mg oral, single dose, morning, 35 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* age: above 18
* depression according DSM-IV

Exclusion Criteria

* bipolar disorder
* substance dependency
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Central Institute of Mental Health

Principal Investigators

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Michael Deuschle, MD

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Locations

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Central Institute of Mental Health

Mannheim, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23277262 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20952454 (View on PubMed)

Other Identifiers

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DFG De 660/1-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AmiPar

Identifier Type: -

Identifier Source: org_study_id

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