EUCTR2006-003658-47-FR
Active, not recruiting
Phase 1
Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.
Pierre Fabre Médicament - IRPF0 sites180 target enrollmentAugust 25, 2006
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pierre Fabre Médicament - IRPF
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Out patient, aged 18 years to 70 years
- •\- Male, or female of childbearing potential using a medically accepted and well documented method of contraception (e.g. oral contraceptives, intrauterine devices, patch, contraceptive implant...) during 2 months before the inclusion in the study, documented sterility or postmenopause (one year amenorrhoea)
- •\- Meeting DSM IV\-TR criteria for Major Depressive Disorder diagnosed using a structured interview (MINI) moderate or severe, recurrent, unipolar, without psychotic features
- •\- Total score MADRS \> or \= to 23 at selection and inclusion visits
- •\- Without any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters
- •\- Patient having signed the written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •Psychiatric criteria
- •\- Patient at significant suicidal risk as assessed with the MINI 5\.0\.0 \- section C
- •\- Resistance to two well\-conducted antidepressant treatments (defined by the lack of response to at least two treatments prescribed at their optimal dose and during at least 4 weeks) for the current episode
- •\- Any history of psychotic episode or disorder
- •\- Any history of bipolar disorder
- •\- Any current panic disorder, agoraphobia, or obsessive compulsive disorder, generalised anxiety disorder or post traumatic stress disorder whose onset preceded the onset of the depressive disorder (diagnosis confirmed with MINI) .
- •\- Current major personality disorder of clinical significance or any other condition that might affect compliance (Cluster A, B and C ex: borderline, paranoid, histrionic, avoidant…)
- •\- History of alcohol and/or drug abuse and/or dependence, except tobacco according to DSM IV\-TR criteria in the 12 months preceding inclusion
- •Somatic criteria
- •\- Severe underlying or ongoing systemic disease that could interfere with the study
Outcomes
Primary Outcomes
Not specified
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