Amitriptyline and Paroxetine Treatment of Major Depression

Central Institute of Mental Health, Mannheim

Status and phase: Completed; Phase 3

Conditions: Unipolar Depression

Treatments: Drug: paroxetine; Drug: amitriptyline

Study type: Interventional

Funder types: Other

Identifiers

NCT01049347

DFG De 660/1-1 (Other Grant/Funding Number)

AmiPar

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age: above 18
• depression according DSM-IV

Exclusion criteria

• bipolar disorder
• substance dependency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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127 participants in 2 patient groups

amitriptyline

Active Comparator group

Treatment:

Drug: amitriptyline

paroxetine

Active Comparator group

Treatment:

Drug: paroxetine