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Citalopram vs Clomipramine vs Placebo in Recurrent Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01575158
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Danish University Antidepressant Group
Information provided by (Responsible Party):
University of Aarhus

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

Condition or disease Intervention/treatment Phase
Depression Drug: Citalopram Drug: Clomipramine Drug: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 1997
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Arm Intervention/treatment
Experimental: citalopram
Drug: Citalopram
Active Comparator: clomipramnine
Drug: Clomipramine
Placebo Comparator: placebo
Drug: placebo

Primary Outcome Measures :
  1. 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 Measures :
  1. Study termination due to adverse event or non-compliance [ Time Frame: 2 years of follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Responsible Party: University of Aarhus Identifier: NCT01575158    
Other Study ID Numbers: DUAG-5
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antidepressive Agents, Tricyclic