Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

Phase 2

Terminated

• Conditions: Major Depression
• Interventions: Drug: DU125530; Drug: Placebo

• Registration Number: NCT01119430
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-05
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2010-05
• Study First Submitted: 2010-05-06
• Study First Submitted QC: 2010-05-06
• Last Update Submitted: 2010-05-06
• Study First Posted: 2010-05-07
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoxetine plus DU125530	DU125530	-
Fluoxetine plus placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Scores on Hamilton Depression Rating Scale	8 time points through 8 weeks

Trial Locations

Locations (1)

Hospital de Sant Pau; 🇪🇸 Barcelona, Spain