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Citalopram vs Clomipramine vs Placebo in Recurrent Depression

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ClinicalTrials.gov Identifier: NCT01575158
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : April 11, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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
Depression Drug: Citalopram Drug: Clomipramine Drug: placebo

Study Design

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
Primary Completion Date : September 2007
Study Completion Date : September 2007


Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575158     History of Changes
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Clomipramine
Dexetimide
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Antidepressive Agents, Tricyclic