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| Descriptive Information Fields | |||||
| Brief Title † | Major Depressive Disorder Study In Adults | ||||
| Official Title † | An Open Label Study Assessing Paxil CR (Paroxetine CR) in Patients With Major Depressive Disorder Who Discontinued Treatment With Selective Serotonin Reuptake Inhibitors or a Selective Serotonin/Norepinephrine Reuptake Inhibitor Due to Intolerability | ||||
| Brief Summary | A study to obtain safety and tolerability data |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Safety Study | ||||
| Primary Outcome Measure † | The proportion of patients who prematurely terminated treatment due to treatment emergent adverse events | ||||
| Secondary Outcome Measure † | Recurrence rates of adverse events causing intolerability of previous SSRI/SNRI, Adverse event incidence rates, Mean change from baseline in the Beck Depression Inventory-II total score, Proportion of responsers based on teh CGI Global Improvement Item | ||||
| Condition † | Major Depressive Disorder | ||||
| Intervention † | Drug: paroxetine CR | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 646 | ||||
| Start Date † | September 2002 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00049972 | ||||
| Organization ID | SB29060.833 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | GlaxoSmithKline | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | GlaxoSmithKline | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | November 18, 2002 | ||||
| Last Updated Date | January 15, 2008 | ||||