Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

Major Depression Clinical Trial

Official title:

Fluoxetine Versus Fluoxetine Plus DU125530 in Latency of Antidepressant Response Shortening in Major Depressive Disorder

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01119430
• Other study ID #: HSP-2003-01
• Status: Terminated
• Phase: Phase 2
• First received: May 6, 2010
• Last updated: May 6, 2010
• Start date: May 2004
• Est. completion date: November 2007

Study information

• Verified date: May 2010
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• DU125530
20mg/twice a day
• Placebo
Similar pill as active comparator twice a day

Locations

Country	Name	City	State
Spain	Hospital de Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on Hamilton Depression Rating Scale		8 time points through 8 weeks	No