Last updated: 11/19/2019 17:30:16
A multicentre, double-blind, randomised dose titration study comparing the pharmacodynamics and pharmacokinetics of paroxetine 20mg increasing to 30mg daily and amitriptyline 100mg increasing to 150mg daily in geriatric patients (age >65 years) with major depression.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A multicentre, double-blind, randomised dose titration study comparing the pharmacodynamics and pharmacokinetics of paroxetine 20mg increasing to 30mg daily and amitriptyline 100mg increasing to 150mg daily in geriatric patients (age >65 years) with major depression.
Trial description: A multicentre, double-blind, randomised dose titration study comparing the pharmacodynamics and pharmacokinetics of paroxetine 20mg increasing to 30mg daily and amitriptyline 100mg increasing to 150mg daily in geriatric patients (age >65 years) with major depression.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
1990-01-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
A pharmacokinetic dose titration study in adult and elderly depressed patients. Hebenstreit, G. F., Fellerer, K., Zochling, R., Zentz, A., and Dunbar, G. C. Acta Psychiatr Scand Suppl 89; 350(81-4)
Hebenstreit GF et al. A multicenter, double-blind, randomized dose titration study comparing the efficacy and tolerability of oral paroxetine and amitriptyline in geriatric patients with major depression. European Neuropsychopharmacology 1991; 1:440-441(poster presentation)
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
August 1988 to August 1990
Type
Interventional
Phase
3
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
1990-01-08
Actual study completion date
1990-01-08
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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