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Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

NCT ID: NCT01119430

Last Updated: 2010-05-07

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

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-11-30

Brief Summary

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The purpose of this study is to examine whether the speed of the clinical antidepressant action of fluoxetine can be accelerated by administering DU125530 a full 5-HT1A antagonist.

Detailed Description

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SSRI acts by blocking the serotonin transporter (5-HT), increasing the availability of serotonin at the synaptic cleft averting its reuptake. The increment of serotonin activates 5-HT1A presynaptic autoreceptors, resulting in a modulation in the release of serotonin by the presynaptic neuron. It is proposed that 5-HT1A receptor antagonism could accelerate the clinical effect of antidepressants by preventing this negative feedback.Preclinical data obtained with selective 5-HT1A antagonists, such as pindolol, and with mice lacking 5-HT1a receptors supports this hypothesis. Results on partial antagonists (pindolol) are conclusive in accelerating SSRI. It is reasonable to call into question whether a total antagonism of 5-HT1a receptors could imply a more rapid antidepressant response. To test this hypothesis we conducted a double blind, randomised, controlled trial with DU 123550 added to fluoxetine 20 mg/day

Conditions

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Major Depression

Keywords

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major depression DU 125530 Treatment depression Latency antidepressant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluoxetine plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Similar pill as active comparator twice a day

Fluoxetine plus DU125530

Group Type ACTIVE_COMPARATOR

DU125530

Intervention Type DRUG

20mg/twice a day

Interventions

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DU125530

20mg/twice a day

Intervention Type DRUG

Placebo

Similar pill as active comparator twice a day

Intervention Type DRUG

Other Intervention Names

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Fluoxetine+DU Fluoxetine+placebo

Eligibility Criteria

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Inclusion Criteria

* Consecutive eligible patients aged 18 to 70
* Diagnosis of unipolar major depression using DSM-IV criteria with moderate to severe symptoms (score e 18 on the Hamilton Depression Rating Scale-HDRS- of 17 items).
* There was a wash-out of 1 week of any antidepressant drug (specifically 28 days for fluoxetine) prior entering the study.
* Written informed consent was obtained from all participants.

Exclusion Criteria

* Concurrent psychiatric disorders (DSM IV axis I, II cluster A or B)
* Failure to respond to drug treatment in current depressive episode
* Previous resistance to SSRIs or other antidepressant drug
* Suicide risk score e 3 on the HDRS.
* Participation in other drug trials within the previous month
* Presence of delusions or hallucinations
* History of substance abuse (including alcohol) in the past three months
* Pregnancy or lactation
* Organic brain disease or history of seizures
* Serious organic illnesses such as hypo or hyperthyroidism,cardiac arrhythmias, asthma, diabetes mellitus.
* Myocardial infarction in the past 6 month
* Frequent or severe allergic reactions
* Concomitant use of other psychotropic drugs (benzodiazepines were allowed), lockers or catecholamine-depleting agents
* Current structured psychotherapy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

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

Principal Investigators

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Victor Pérez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Psychiatrist, Hospital de Sant Pau

Enric Álvarez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Head of Departement, Psiquiatria, Hospital de Sant Pau

Dolors Puigdemont, MD

Role: STUDY_CHAIR

Psychiatrist, Hospital de Sant Pau

Josefina Pérez, MD

Role: STUDY_DIRECTOR

Psychiatrist, Hospital de Sant Pau

Locations

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Hospital de Sant Pau

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Scorza MC, Llado-Pelfort L, Oller S, Cortes R, Puigdemont D, Portella MJ, Perez-Egea R, Alvarez E, Celada P, Perez V, Artigas F. Preclinical and clinical characterization of the selective 5-HT(1A) receptor antagonist DU-125530 for antidepressant treatment. Br J Pharmacol. 2012 Nov;167(5):1021-34. doi: 10.1111/j.1476-5381.2011.01770.x.

Reference Type DERIVED
PMID: 22050051 (View on PubMed)

Other Identifiers

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HSP-2003-01

Identifier Type: -

Identifier Source: org_study_id