Last updated: 11/07/2018 13:59:53
A double-blind, randomised multi centre study to assess the safety and tolerability of paroxetine and amitriptyline in depressed subjects stabilised on lithium treatment
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 double-blind, randomised multi centre study to assess the safety and tolerability of paroxetine and amitriptyline in depressed subjects stabilised on lithium treatment
Trial description: A double-blind, randomised multi centre study to assess the safety and tolerability of paroxetine and amitriptyline in depressed subjects stabilised on lithium treatment
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:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Bauer M, Zaninelli R, Müller-Oerlinghausen B, and Meister W., Paroxetine and amitriptyline augmentation of lithium in the treatment of major depression: a double-blind study. J Clin Psychopharmacol 1999 ; 19 :164-171
Zaninelli R, Bauer M, Jobert M, and Müller-Oerlinghausen B., Changes in quantitatively assessed tremor during treatment of major depression with lithium augmented by paroxetine or amitriptyline J Clin Psychopharmacol 2001;21:190-198
Medical condition
Depressive Disorder
Product
paroxetine
Collaborators
Not applicable
Study date(s)
April 1993 to April 1996
Type
Not applicable
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
Not applicable
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
1996-22-04
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
Not applicable
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