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Amitriptyline and Paroxetine Treatment of Major Depression

C

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

127 participants in 2 patient groups

amitriptyline
Active Comparator group
Treatment:
Drug: amitriptyline
paroxetine
Active Comparator group
Treatment:
Drug: paroxetine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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