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Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT01119430
Recruitment Status : Terminated (interim analysis suggested no differences with whole sample)
First Posted : May 7, 2010
Last Update Posted : May 7, 2010
Sponsor:
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Tracking Information
First Submitted Date  ICMJE May 6, 2010
First Posted Date  ICMJE May 7, 2010
Last Update Posted Date May 7, 2010
Study Start Date  ICMJE May 2004
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2010)
Scores on Hamilton Depression Rating Scale [ Time Frame: 8 time points through 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder
Official Title  ICMJE Fluoxetine Versus Fluoxetine Plus DU125530 in Latency of Antidepressant Response Shortening in Major Depressive Disorder
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE
  • Drug: DU125530
    20mg/twice a day
    Other Name: Fluoxetine+DU
  • Drug: Placebo
    Similar pill as active comparator twice a day
    Other Name: Fluoxetine+placebo
Study Arms  ICMJE
  • Placebo Comparator: Fluoxetine plus placebo
    Intervention: Drug: Placebo
  • Active Comparator: Fluoxetine plus DU125530
    Intervention: Drug: DU125530
Publications * Scorza MC, Lladó-Pelfort L, Oller S, Cortés R, Puigdemont D, Portella MJ, Pérez-Egea R, Alvarez E, Celada P, Pérez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 6, 2010)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01119430
Other Study ID Numbers  ICMJE HSP-2003-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Victor Pérez, MD, PhD Psychiatrist, Hospital de Sant Pau
Principal Investigator: Enric Álvarez, MD, PhD Head of Departement, Psiquiatria, Hospital de Sant Pau
Study Chair: Dolors Puigdemont, MD Psychiatrist, Hospital de Sant Pau
Study Director: Josefina Pérez, MD Psychiatrist, Hospital de Sant Pau
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP