Citalopram vs Clomipramine vs Placebo in Recurrent Depression

This study has been completed.
Sponsor:
Collaborator:
Danish University Antidepressant Group
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01575158
First received: April 10, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

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


Condition Intervention
Depression
Drug: Citalopram
Drug: Clomipramine
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Study termination due to adverse event or non-compliance [ Time Frame: 2 years of follow-up ] [ Designated as safety issue: Yes ]

Enrollment: 59
Study Start Date: October 1997
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: citalopram
citalopram
Drug: Citalopram
Active Comparator: clomipramnine
clomipramine
Drug: Clomipramine
Placebo Comparator: placebo
placebo
Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575158     History of Changes
Other Study ID Numbers: DUAG-5
Study First Received: April 10, 2012
Last Updated: April 10, 2012
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Clomipramine
Citalopram
Dexetimide
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on August 20, 2014