Amitriptyline and Paroxetine Treatment of Major Depression

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01049347

Enrollment

127

Registered

2010-01-14

Start date

1997-10-31

Completion date

2000-05-31

Last updated

2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unipolar Depression

Keywords

depression

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.

Interventions

DRUGamitriptyline

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

DRUGparoxetine

40 mg oral, single dose, morning, 35 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age: above 18 * depression according DSM-IV

Exclusion criteria

* bipolar disorder * substance dependency

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale (21-item version)	baseline, weekly assessments for 5 weeks

Secondary

Measure	Time frame
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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026