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
About this trial
This is an interventional treatment trial for Depression
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
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
NCT ID
NCT01575158
First Posted
April 10, 2012
Last Updated
April 10, 2012
Sponsor
University of Aarhus
Collaborators
Danish University Antidepressant Group
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
Learn more about this trial
Citalopram vs Clomipramine vs Placebo in Recurrent Depression
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