Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depre... | NCT01119430

Studies
Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

NCT01119430

Sponsor

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

Status

Terminated

Last Update Posted

May 7, 2010Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Major Depression

Interventions

DU125530
Placebo

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

interim analysis suggested no differences with whole sample

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Nov 2007Actual

Completion Date

Nov 2007Actual

First Submitted Date

May 6, 2010

First Submission Date that Met QC Criteria

May 6, 2010

First Posted Date

May 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2010

Last Update Posted Date

May 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fluoxetine plus placebo	Placebo Comparator		Drug: Placebo
Fluoxetine plus DU125530	Active Comparator		Drug: DU125530

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DU125530	Drug	20mg/twice a day	Fluoxetine plus DU125530	Fluoxetine+DU

Measure	Description	Time Frame
Scores on Hamilton Depression Rating Scale		8 time points through 8 weeks

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Victor Pérez, MD, PhD	Psychiatrist, Hospital de Sant Pau	Principal Investigator
Enric Álvarez, MD, PhD	Head of Departement, Psiquiatria, Hospital de Sant Pau	Principal Investigator
Dolors Puigdemont, MD	Psychiatrist, Hospital de Sant Pau	Study Chair
Josefina Pérez, MD	Psychiatrist, Hospital de Sant Pau	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Sant Pau		Barcelona	Barcelona	08027	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22050051	Derived	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.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders