Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder

NCT ID: NCT00931775

Last Updated: 2009-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2005-11-30

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder Antidepressant Treatment Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Citalopram + placebo

Citalopram 20 mg/day t.i.d

Group Type PLACEBO_COMPARATOR

Pindolol

Intervention Type DRUG

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

Citalopram + pindolol

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

Group Type EXPERIMENTAL

Pindolol

Intervention Type DRUG

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

Interventions

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Pindolol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* suicidal risk \> 3
* severe organic illness
* other psychotropic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role lead

Responsible Party

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Hospital de la Santa Creu i Sant Pau. Psychiatry Department

Principal Investigators

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Enric Álvarez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Víctor Pérez, MD, PhD

Role: STUDY_DIRECTOR

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

Francesc Artigas, PhD

Role: STUDY_CHAIR

Neurochemistry department. Consejo Superior de Investigaciones Científicas

Locations

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

Barcelona, Catalonia, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 21034693 (View on PubMed)

Other Identifiers

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CIT-PIN_01-0C3

Identifier Type: -

Identifier Source: org_study_id

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