Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510822
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2007-08-01
Brief Title:
Cimicoxib for the Treatment of Major Depression SECIM
Sponsor:
Affectis Pharmaceuticals AG
Organization:
Affectis Pharmaceuticals AG
Study Overview
Official Title:
Safety and Efficacy of Cimicoxib a Selective COX-2 Inhibitor in Combination With Sertraline Compared to Sertraline Combined With Placebo in Treatment of Major Depression
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This multicenter study aims to investigate the safety and efficacy of cimicoxib a selective COX-2 inhibitor in combination with sertraline compared to sertraline combined with placebo in patients with major depression This clinical study is based on the assumption that adjunctive treatment of major depression with a COX-2 inhibitor may be beneficial
Detailed Description:
Adult patients of both gender aged between 18 and 60 years diagnosed with major depression by a psychiatrist and a HamD-17 score 22 will be enrolled All patients will undergo a wash out period of 3 days without eg medication or antidepressant medication prior to receiving sertraline combined with cimicoxib or placebo In the exceptional case where in opinion of the investigator concomitant psychotic treatment is needed up to 3 mg lorazepam daily can additionally be administrated during this period and the first two weeks of treatmentAssessment of HamD-17 will be performed by trained psychiatric raters before wash out and at week 0 baseline prior to the treatment If the HamD-17 score decreases to less than 22 at the second rating patients will be excluded from studyPatient must be in-patients during the wash out period and the first two weeks of treatment Upon recommendation of the investigator participants can become out-patients with ambulatory care at day clinics after the first two weeks of treatmentAt baseline week 0 patients will be randomised to one of the following treatment arms 50 mg of sertraline one tabletunblinded daily plus cimicoxib one tablet-50mg twice daily 50 mg of sertraline one tabletunblinded daily plus placebo one tablet twice daily If at study visit 3 ie after 3 weeks of treatment the baseline therapy dose of 50 mg of sertraline daily is considered as not therapeutically sufficient increase of HamD-17 by more than 20 compared to baseline it can be increased to 100 mg daily at the discretion of the investigator The decision by the investigator to increase sertraline dose to 100 mg daily is allowed only at study visit 3 and is not permitted at any other time during the studyDuring the double-blind period study visits will take place every week until week 6 and clinical psychiatric and safety assessments will be performed Four weeks after the end of treatment the investigators or their designees will call the patients to capture information on how the patients feel and to assess if the patients experienced any SAEAEs eg hospitalisations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-No 2007-001335-54 | None | None | None |