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Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

Primary Purpose

Major Depression

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DU125530
Placebo
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 Depression focused on measuring major depression, DU 125530, Treatment depression, Latency antidepressant

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Fluoxetine plus placebo

Fluoxetine plus DU125530

Arm Description

Outcomes

Primary Outcome Measures

Scores on Hamilton Depression Rating Scale

Secondary Outcome Measures

Full Information

First Posted
May 6, 2010
Last Updated
May 6, 2010
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
NCT01119430
Brief Title
Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder
Official Title
Fluoxetine Versus Fluoxetine Plus DU125530 in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Terminated
Why Stopped
interim analysis suggested no differences with whole sample
Study Start Date
May 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
major depression, DU 125530, Treatment depression, Latency antidepressant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoxetine plus placebo
Arm Type
Placebo Comparator
Arm Title
Fluoxetine plus DU125530
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
DU125530
Other Intervention Name(s)
Fluoxetine+DU
Intervention Description
20mg/twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Fluoxetine+placebo
Intervention Description
Similar pill as active comparator twice a day
Primary Outcome Measure Information:
Title
Scores on Hamilton Depression Rating Scale
Time Frame
8 time points through 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Pérez, MD, PhD
Organizational Affiliation
Psychiatrist, Hospital de Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Enric Álvarez, MD, PhD
Organizational Affiliation
Head of Departement, Psiquiatria, Hospital de Sant Pau
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dolors Puigdemont, MD
Organizational Affiliation
Psychiatrist, Hospital de Sant Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Josefina Pérez, MD
Organizational Affiliation
Psychiatrist, Hospital de Sant Pau
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Sant Pau
City
Barcelona
ZIP/Postal Code
08027
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22050051
Citation
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.
Results Reference
derived

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Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

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