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Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01119430
Recruitment Status : Terminated (interim analysis suggested no differences with whole sample)
First Posted : May 7, 2010
Last Update Posted : May 7, 2010
Information provided by:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: DU125530 Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fluoxetine Versus Fluoxetine Plus DU125530 in Latency of Antidepressant Response Shortening in Major Depressive Disorder
Study Start Date : May 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Arm Intervention/treatment
Placebo Comparator: Fluoxetine plus placebo Drug: Placebo
Similar pill as active comparator twice a day
Other Name: Fluoxetine+placebo

Active Comparator: Fluoxetine plus DU125530 Drug: DU125530
20mg/twice a day
Other Name: Fluoxetine+DU

Primary Outcome Measures :
  1. Scores on Hamilton Depression Rating Scale [ Time Frame: 8 time points through 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01119430

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Hospital de Sant Pau
Barcelona, Spain, 08027
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Identifier: NCT01119430     History of Changes
Other Study ID Numbers: HSP-2003-01
First Posted: May 7, 2010    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
major depression
DU 125530
Treatment depression
Latency antidepressant
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors