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Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder (CIT-PIN)

This study has been completed.
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier:
NCT00931775
First received: July 1, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted

July 1, 2009
July 1, 2009
December 2002
March 2005   (final data collection date for primary outcome measure)
Scores on Hamilton Depression Rating Scale [ Time Frame: 8 time points through 6 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder

The purpose of this study is to examine whether the speed of the clinical antidepressant action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day, tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.

Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram + placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected from a general hospital.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Major Depressive Disorder
  • Antidepressant Treatment Response
Drug: Pindolol
Pill orally administered. 15 mg/day t.i.d.
  • Placebo Comparator: Citalopram + placebo
    Citalopram 20 mg/day t.i.d
    Intervention: Drug: Pindolol
  • Experimental: Citalopram + pindolol
    Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d.
    Intervention: Drug: Pindolol
Portella MJ, de Diego-Adeliño J, Ballesteros J, Puigdemont D, Oller S, Santos B, Álvarez E, Artigas F, Pérez V. Can we really accelerate and enhance the selective serotonin reuptake inhibitor antidepressant effect? A randomized clinical trial and a meta-analysis of pindolol in nonresistant depression. J Clin Psychiatry. 2011 Jul;72(7):962-9. doi: 10.4088/JCP.09m05827blu. Epub 2010 Oct 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2005
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with a depressive episode
  • HDRS score > 18
  • Written informed consent

Exclusion Criteria:

  • suicidal risk > 3
  • severe organic illness
  • other psychotropic drugs
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00931775
CIT-PIN_01-0C3
Yes
Enric Álvarez / Víctor Pérez, Hospital de la Santa Creu i Sant Pau. Psychiatry Department
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Not Provided
Principal Investigator: Enric Álvarez, MD, PhD Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Study Director: Víctor Pérez, MD, PhD Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Study Chair: Francesc Artigas, PhD Neurochemistry department. Consejo Superior de Investigaciones Científicas
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP