Last updated: 11/07/2018 13:58:38
A double blind, placebo controlled study to determine the effects of subchronic paroxetine treatment on nocturnal hormonal secretion and sleep in healthy male volunteers
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, placebo controlled study to determine the effects of subchronic paroxetine treatment on nocturnal hormonal secretion and sleep in healthy male volunteers
Trial description: A double blind, placebo controlled study to determine the effects of subchronic paroxetine treatment on nocturnal hormonal secretion and sleep in healthy male volunteers
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:
Analysis of sleep eeg microstructure in subchronic paroxetine treatment of healthy subjects. Roschke, J., Kogel, P., Schlosser, R., Wagner, P., Mann, K., Rossbach, W., and Benkert, O. Psychopharmacology (Berl) 97; 132(1):44-9
Effects of subchronic paroxetine administration on night-time endocrinological profiles in healthy male volunteers. Schlosser, R., Wetzel, H., Dorr, H., Rossbach, W., Hiemke, C., and Benkert, O. Psychoneuroendocrinology 2000; 25(4):377-88
Effects of subchronic paroxetine administration on sleep eeg and night-time endocrinological profiles in healthy male volunteers. Wetzel, H, Schlober, R, Rossbach, Wl Dorr H, Roschke, H, Hiemke, Ch, and Benkert, O 26th Congress of the International Society of Psychoneuroendocrinology 9/11/1995 Munich; Germany
The effects of subchronic paroxetine administration on sleep eeg and night-time endocrinological profiles in healthy male volunteers. Schlosser, R, Wetzel, H, Roschke, J, Grunder, G, Rossbach, W, Dorr, H, Hiemke, Ch, and Benkert, O 6th World Congress of Biological Psychiatry 6/22/1997 Nice; France
Medical condition
Mental Disorders
Product
paroxetine
Collaborators
Not applicable
Study date(s)
February 1993 to June 1994
Type
Not applicable
Phase
1
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
1994-24-06
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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