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

Primary Purpose

Major Depressive Disorder, Antidepressant Treatment Response

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Pindolol
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major depressive disorder, citalopram, pindolol, HDRS

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • suicidal risk > 3
  • severe organic illness
  • other psychotropic drugs

Sites / Locations

  • Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Citalopram + placebo

Citalopram + pindolol

Arm Description

Citalopram 20 mg/day t.i.d

Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d.

Outcomes

Primary Outcome Measures

Scores on Hamilton Depression Rating Scale

Secondary Outcome Measures

Full Information

First Posted
July 1, 2009
Last Updated
July 1, 2009
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT00931775
Brief Title
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
Acronym
CIT-PIN
Official Title
Citalopram Versus Citalopram Plus Pindolol in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Antidepressant Treatment Response
Keywords
Major depressive disorder, citalopram, pindolol, HDRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Citalopram + placebo
Arm Type
Placebo Comparator
Arm Description
Citalopram 20 mg/day t.i.d
Arm Title
Citalopram + pindolol
Arm Type
Experimental
Arm Description
Citalopram 20 mg/day t.i.d Pindolol 15 mg/day t.i.d.
Intervention Type
Drug
Intervention Name(s)
Pindolol
Intervention Description
Pill orally administered. 15 mg/day t.i.d.
Primary Outcome Measure Information:
Title
Scores on Hamilton Depression Rating Scale
Time Frame
8 time points through 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with a depressive episode HDRS score > 18 Written informed consent Exclusion Criteria: suicidal risk > 3 severe organic illness other psychotropic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enric Álvarez, MD, PhD
Organizational Affiliation
Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Víctor Pérez, MD, PhD
Organizational Affiliation
Department of Psychiatry. Hospital de la Santa Creu i Sant Pau
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Francesc Artigas, PhD
Organizational Affiliation
Neurochemistry department. Consejo Superior de Investigaciones Científicas
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatients Service of Psychiatry Department. Hospital de la Santa Creu i Sant Pau
City
Barcelona
State/Province
Catalonia
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21034693
Citation
Portella MJ, de Diego-Adelino J, Ballesteros J, Puigdemont D, Oller S, Santos B, Alvarez E, Artigas F, Perez 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.
Results Reference
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Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder

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