NCT00931775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Dec 2002

Typical duration for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
Last Updated

July 2, 2009

Status Verified

July 1, 2009

Enrollment Period

2.2 years

First QC Date

July 1, 2009

Last Update Submit

July 1, 2009

Conditions

Major Depressive DisorderAntidepressant Treatment Response

Keywords

Major depressive disorder, citalopram, pindolol, HDRS

Outcome Measures

Primary Outcomes (1)

  • Scores on Hamilton Depression Rating Scale

    8 time points through 6 weeks

Study Arms (2)

Citalopram + placebo

PLACEBO COMPARATOR

Citalopram 20 mg/day t.i.d

Drug: Pindolol

Citalopram + pindolol

EXPERIMENTAL

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

Drug: Pindolol

Interventions

PindololDRUG

Pill orally administered. 15 mg/day t.i.d.

Citalopram + pindololCitalopram + placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Barcelona, Catalonia, 08025, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21034693DERIVED

MeSH Terms

Conditions

Depressive Disorder, MajorBarakat syndrome

Interventions

Pindolol

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Enric Álvarez, MD, PhD

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

    PRINCIPAL INVESTIGATOR

  • Víctor Pérez, MD, PhD

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

    STUDY DIRECTOR

  • Francesc Artigas, PhD

    Neurochemistry department. Consejo Superior de Investigaciones Científicas

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2009

First Posted

July 2, 2009

Study Start

December 1, 2002

Primary Completion

March 1, 2005

Study Completion

November 1, 2005

Last Updated

July 2, 2009

Record last verified: 2009-07

Locations

ES(1)