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OpenTrials
Completed

NCT Number: NCT01049347

Amitriptyline and Paroxetine Treatment of Major Depression

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.

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Key information

Conditions

Unipolar Depression Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Central Institute of Mental Health

Mannheim, 68159, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age: above 18
  • depression according DSM-IV

Exclusion criteria

  • bipolar disorder
  • substance dependency

Treatment and study plan

Amitriptyline

Drug

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

paroxetine

Drug

40 mg oral, single dose, morning, 35 days

Primary outcomes

  1. Hamilton Depression Rating Scale (21-item version)

    Time frame: 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

    Time frame: daily during wash-out (days -6 to -1) and active treatment (days 1 to 35)

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2000
Study completion
2000
First posted
Jan 14, 2010
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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