Fluoxetine Versus Fluoxetine Plus DU125530 in Major Depressive Disorder

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.