Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

• Status: Terminated
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Treatments: Antidepressive Agents; Fluoxetine

Criteria

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.