Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Despite the availability of a wide range of antidepressant drugs, clinical trials indicate
      that 30% to 40% of patients with major depression fail to respond to first-line
      antidepressant treatment, despite adequate dosage, duration, and compliance. Moreover, in
      those patients who do experience symptomatic relief following conventional anti-depressant
      treatment, clinical improvement is not evident for 3-4 weeks. Thus, there is a clear need to
      develop novel and improved therapeutics for unipolar depression.

      A previous study showed that the intravenous administration of scopolamine produces
      antidepressant effects. This study is designed to determine if scopolamine combine with
      Escitalopram produce antidepressant effects at an early stage.
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled clinical trial. Sixty-six
      outpatients (ages 18-45) with severe major depressive disorder (MDD) (17-item Hamilton Rating
      Scale for Depression total score greater than or equal to 20) are enrolled from Beijing
      Anding Hospital. All participants receive oral escitalopram 10 mg/d throughout the total of 4
      weeks treatment. Meanwhile, they are randomized equally to one of three add-on treatment arms
      during the first three days: (1) intramuscular injection (i.m.) with saline (1 ml) at 9 am
      and 3 pm per day; (2) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and saline (1 ml,
      i.m.) at 3 pm per day; (3) scopolamine (0.3 mg in 1ml saline, i.m.) at 9 am and 3 pm per day,
      respectively. Patients were assessed at baseline, day 2, day 3, day 4, day 7, day 14, and day
      28 using 17-Item Hamilton Depression Rating Scale(HAMD-17), Montgomery-Asberg Depression
      Rating Scale(MADRS), Young Mania Rating Scale(YMRS), Generalized Anxiety Disorder-7(GAD-7),
      Quick Inventory of Depressive Symptomatology Self-report 16(QIDS-SR16) and Clinical Global
      Impression(CGI) by assessors masked to treatment assignments. The primary outcome measure was
      the time from randomization (baseline) to early improvement (at least 20% reduction in
      HAMD-17 score ). The second outcome measures were response rates (at least 50% decrease in
      the HAMD-17 at any visit from baseline), remission rate (HAMD-17 score≤7) at day 28, change
      in HAMD-17 score ,MADRS score, QIDS-SR16 score, GAD7 score and YMRS score from baseline to
      any visit, change in CGI-S from baseline to the end of the trial, and CGI-I score at any
      visit.
    

Intervention name(s): Scopolamine; Escitalopram; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days;; Oral escitalopram 10 mg/d throughout the total of 4 weeks treatment; Intramuscular injection with saline (1ml, QD or Bid) during the first three days;
Intervention MeSH terms: Scopolamine; Escitalopram; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: GROUP 1: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 0.9% saline treatment at 3pm. GROUP 2: The patients received intramuscular injection treatment of scopolamine (0.3 mg/ml) at 9 am and 3 PM. GROUP 3: The patients received intramuscular injection treatment of 0.9% saline (1 ml) at 9 am and 3 PM.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Scopolamine