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Citalopram vs Clomipramine vs Placebo in Recurrent Depression

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Citalopram
Clomipramine
placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with recurrent depression
  • Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode

Exclusion Criteria:

  • Contraindications to study medications
  • Pregnancy
  • Substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    citalopram

    clomipramnine

    placebo

    Arm Description

    citalopram

    clomipramine

    placebo

    Outcomes

    Primary Outcome Measures

    2 Hamilton Depression Rating Scale scores of at least 16 with one weeks interval or initiation of another antidepressant treatment

    Secondary Outcome Measures

    Study termination due to adverse event or non-compliance

    Full Information

    First Posted
    April 10, 2012
    Last Updated
    April 10, 2012
    Sponsor
    University of Aarhus
    Collaborators
    Danish University Antidepressant Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01575158
    Brief Title
    Citalopram vs Clomipramine vs Placebo in Recurrent Depression
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1997 (undefined)
    Primary Completion Date
    September 2007 (Actual)
    Study Completion Date
    September 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Danish University Antidepressant Group

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    citalopram and clomipramine are better than placebo in preventing new episodes of depression in patients with recurrent depression

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    citalopram
    Arm Type
    Experimental
    Arm Description
    citalopram
    Arm Title
    clomipramnine
    Arm Type
    Active Comparator
    Arm Description
    clomipramine
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Citalopram
    Intervention Type
    Drug
    Intervention Name(s)
    Clomipramine
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Primary Outcome Measure Information:
    Title
    2 Hamilton Depression Rating Scale scores of at least 16 with one weeks interval or initiation of another antidepressant treatment
    Time Frame
    2 years of follow-up
    Secondary Outcome Measure Information:
    Title
    Study termination due to adverse event or non-compliance
    Time Frame
    2 years of follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with recurrent depression Sustained response achieved (3 consecutive monthly ratings at the HDS below 13)after a treatment requiring index episode Exclusion Criteria: Contraindications to study medications Pregnancy Substance abuse

    12. IPD Sharing Statement

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    Citalopram vs Clomipramine vs Placebo in Recurrent Depression

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