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

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.
 
ClinicalTrials.gov Identifier: NCT00931775
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : July 2, 2009
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE July 1, 2009
First Posted Date  ICMJE July 2, 2009
Last Update Posted Date July 2, 2009
Study Start Date  ICMJE December 2002
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2009)
Scores on Hamilton Depression Rating Scale [ Time Frame: 8 time points through 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
Official Title  ICMJE Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depressive Disorder
  • Antidepressant Treatment Response
Intervention  ICMJE Drug: Pindolol
Pill orally administered. 15 mg/day t.i.d.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2009)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2005
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • suicidal risk > 3
  • severe organic illness
  • other psychotropic drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00931775
Other Study ID Numbers  ICMJE CIT-PIN_01-0C3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Enric Álvarez / Víctor Pérez, Hospital de la Santa Creu i Sant Pau. Psychiatry Department
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date July 2009

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