A Safety and Effectiveness Study of JNJ-18038683 in Patients With Moderate to Severe Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of JNJ-18038683
      compared to escitalopram and placebo in patients with moderate to severe depression.
    

Detailed description: 
      This study is being done to assess safety and tolerability and to explore the effectiveness
      of a new, experimental drug in the treatment of moderate to severe depression. Approximately
      225 patients with depression will be recruited for the study. Patients who meet study
      criteria will need to stop taking any depression medications they are currently using. They
      will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of
      receiving 20 mg JNJ-18038683, 20 mg escitalopram, or placebo. Placebo has no active drug.
      Escitalopram is a drug currently approved to treat depression. This is a blinded study, ie
      the patient, the study doctor, and the study sponsor will not know what treatment the patient
      receives until all patients complete the study. Patients receiving either escitalopram or
      JNJ-18038683 will be titrated up to their assigned dose, receiving 10 mg doses for one week
      prior to increasing to 20 mg. Patients who are not able to tolerate 20 mg of JNJ-18038683
      will be allowed to drop down to the 10 mg dose at any time after the titration period.
      Patients taking 20 mg escitalopram will receive 10 mg at their final week to taper off of the
      drug. Patients will receive a drug blister card at each weekly visit containing drug for the
      upcoming week. The study doctor and the sponsor will monitor the study for the occurrence of
      possible side effects. In addition to a screening visit, patients will return weekly for 9
      additional study visits. After completing the study, patients may resume other depression
      medications. Medical and psychiatric history, physical examination, blood pressure, heart
      rate, temperature, weight and electrocardiograms (ECGs) will be checked periodically. Blood
      samples will be taken for standard safety laboratory tests as well as for the measurement of
      the drug blood level. Questionnaires relating to depression, sleep and sexual experience will
      be administered throughout the study. Each day for nine weeks, patients will take orally two
      JNJ-18038683 tablets, active and/or placebo, and two escitalopram capsules, active and/or
      placebo.
    

Intervention name(s): Placebo; Escitalopram; JNJ-18038683
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Form= capsule, route= oral use. Administration once daily for 8 weeks.; Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 20 mg daily for 6 weeks, and 10 mg daily for 1 week.; Type= range, unit= mg, number= 10 to 20, form= capsule, route= oral use. Administration of 10 mg daily for 1 week, 10 or 20 mg daily for 6 weeks, and placebo daily for 1 week.
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; JNJ-18038683; Escitalopram