NCT01119430

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2010

Completed
Last Updated

May 7, 2010

Status Verified

May 1, 2010

Enrollment Period

3.5 years

First QC Date

May 6, 2010

Last Update Submit

May 6, 2010

Conditions

Major Depression

Keywords

major depressionDU 125530Treatment depressionLatency antidepressant

Outcome Measures

Primary Outcomes (1)

  • Scores on Hamilton Depression Rating Scale

    8 time points through 8 weeks

Study Arms (2)

Fluoxetine plus placebo

PLACEBO COMPARATOR
Drug: Placebo

Fluoxetine plus DU125530

ACTIVE COMPARATOR
Drug: DU125530

Interventions

DU125530DRUG

20mg/twice a day

Also known as: Fluoxetine+DU
Fluoxetine plus DU125530
PlaceboDRUG

Similar pill as active comparator twice a day

Also known as: Fluoxetine+placebo
Fluoxetine plus placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Sant Pau

Barcelona, Barcelona, 08027, Spain

Location

Related Publications (1)

  • 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.

    PMID: 22050051DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

1,2-benzisothiazol-3(2H)-one, 2-(4-(4-(7-chloro-2,3-dihydro-1,4-benzodioxin-5-yl)-1-piperazinyl)butyl)-, 1,1-dioxide

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Victor Pérez, MD, PhD

    Psychiatrist, Hospital de Sant Pau

    PRINCIPAL INVESTIGATOR

  • Enric Álvarez, MD, PhD

    Head of Departement, Psiquiatria, Hospital de Sant Pau

    PRINCIPAL INVESTIGATOR

  • Dolors Puigdemont, MD

    Psychiatrist, Hospital de Sant Pau

    STUDY CHAIR

  • Josefina Pérez, MD

    Psychiatrist, Hospital de Sant Pau

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 6, 2010

First Posted

May 7, 2010

Study Start

May 1, 2004

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

May 7, 2010

Record last verified: 2010-05

Locations

ES(1)