Citalopram Titration in Early Non-responder Patients With Major Depressive Disorders
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      Major depressive disorder is a common mental disorder and the leading cause of disability
      worldwide. According to the Canadian Network for Mood and Anxiety Treatment, early
      improvement following an antidepressant treatment is correlated with response and remission.
      Escalation of an antidepressant dose after 2 weeks, as opposed to 4 to 8 weeks, is proposed
      to favor early improvement. However, this has never been tested systematically in a
      controlled study involving major depressive disorder patients that are non-responders to
      their antidepressant treatment.
    

Detailed description: 
      The investigators sought to assess whether it is feasible to perform a prospective randomized
      controlled double-blind feasibility study with a 2 week run-in period and 3 parallel groups
      randomized controlled study using citalopram. Citalopram has physicochemical properties
      compatible with over-encapsulation and a has a simple titration that allows the study of
      early dose increase.. It is among the most prescribed antidepressant in the province of
      Quebec and at the Hospital Maisonneuve-Rosemont - University family medicine group (U-FMG).

      Since establishment of a randomized controlled trial is complex and expensive, a feasibility
      design is appropriate to identify all the obstacles and to minimize sources of possible bias
      (recruitment, follow up, resources).
    

Intervention name(s): Citalopram 20mg or 40 mg (phase 2)
Intervention type(s): Drug
Intervention description(s): For non-responders, a randomisation 1:1 was chosen. The group A will receive 40 mg and the group B will receive 20 mg once daily of citalopram for 14 days.
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Preparation phase (Phase 1) : Every enrolled patients start with citalopram 10 mg daily for 3 days and 20 mg daily for 11 days.
Escalation phase (Phase 2) :This phase is split in two arms which are the responders and the non-responders. Responders will pursue their citalopram 20 mg for 14 days. Non-responders will be assigned randomly 1:1 in 2 groups. Patients in group A will be randomized to receive a pill of citalopram 20 mg and a capsule of citalopram 20 mg for 14 days. The total dose of citalopram will be 40 mg once daily. Patients in group B receive a pill of citalopram 20 mg and a capsule of placebo (a capsule without medication) for 14 days. The total dose of citalopram will be 20 mg once daily.
Follow-up phase (Phase 3) : Every responders will pursue their treatment of citalopram 20 mg daily for 28 days. It's possible that in this group, the treatment approach may vary depending the physician. Every non-responders (group A and B) will receive 40 mg of citalopram for 28 days.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: citalopram; major depressive disorder; non responder; MADRS