Adherence to Antidepressant Treatment in Subjects With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Intervention: Escitalopram + RT2CK17; Escitalopram + Placebo
Intervention description: Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.; Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study aims to determine whether a combination a first-line antidepressant plus "RT2CK17"
      in a capsule relative to a first-line antidepressant plus placebo in a capsule results in
      higher rates of medication adherence in individuals with moderate to severe depression. In
      this double-blind randomized placebo controlled trial, 100 individuals with a Quick Inventory
      of Depressive Symptomatology-Self Report (QIDS-SR) scale score ≥ 14 will be enrolled to
      participate in an 8 week treatment study. Participants will be randomized with a 1-1 ratio to
      receive 5 milligrams (mg) "RT2CK17" + 10 mg escitalopram or placebo + 10 mg escitalopram to
      be taken orally once per day. Participants will undergo a 3 hour baseline evaluation visit at
      week 0, two 30-minute office visits (week 2 and 4), one 60-minute office visit (week 8) and
      three 5-minute phone calls (weeks 1, 3, and 6) during which clinical assessments and measures
      will be obtained. The trial is designed with two stages: 20 participants in Stage 1 will be
      used to estimate the adherence effect size; Stage 2 is designed with an interim analysis to
      test our hypotheses.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Baseline QIDS-SR ≥ 14 (moderate depression)

          -  Age 18 - 65

          -  Written Informed Consent

          -  Major Depressive Disorder, single-episode/recurrent, not in remission

        Exclusion Criteria:

          -  RT2CK17-related exclusions

          -  Uncontrolled hyperthyroidism

          -  Glaucoma

          -  Motor tics

          -  Monoamine oxidase inhibitor treatment

          -  Serious coronary artery disease, cardiomyopathy, serious cardiac arrhythmias

          -  Uncontrolled hypertension

          -  Peripheral vasculopathy

          -  Pregnancy

          -  Bipolar Disorder

          -  Psychotic Disorder

          -  History of intolerability of study medications

          -  Currently taking psychiatric medications

          -  Current Substance Use Disorder (other than nicotine)

          -  Current Alcohol Use Disorder