Cimicoxib for the Treatment of Major Depression (SECIM)
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

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 e.g. 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
      treatment.Assessment 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 study.Patient 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 treatment.At baseline (week 0) patients will be randomised to one of
      the following treatment arms:· 50 mg of sertraline (one tablet/unblinded) daily plus
      cimicoxib (one tablet-50mg) twice daily.· 50 mg of sertraline (one tablet/unblinded) daily
      plus placebo (one tablet) twice daily If at study visit 3 (i.e. 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 study.During 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 SAE/AEs (e.g. hospitalisations).
    

Intervention name(s): Cimicoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg per tablet, bid (total daily dose 100 mg); tablet
Other intervention name(s): AFX; PLC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cimicoxib; Cox-2 inhibitor; Sertraline