A randomised, double-blind, parallel-group, placebo-controlled and active-referenced study evaluating the efficacy and safety of three fixed dose regimens of Lu AA34893 in the treatment of Major Depressive Disorder.
- Conditions
- Major Depressive DisorderMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS
- Registration Number
- EUCTR2007-007025-51-EE
- Lead Sponsor
- H. Lundbeck A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 600
A patient, who meets all the following criteria, both at the Screening Visit and at the Baseline Visit, is eligible for inclusion in this study:
1. The patient is able to read and understand the Subject Information Sheet.
2. The patient has signed the Informed Consent Form.
3. The patient suffers from a MDE as the principal diagnosis according to DSM-IV-TR
(classification code 296.xx) as assessed by the MINI.
4. The reported duration of the current Major Depressive Episode is at least 3 months.
5. The patient has a MADRS total score =26.
6. The patient is a man or woman, aged between 18 and 75 years (extremes included).
7. The patient is an in-patient in a psychiatric hospital or an out-patient at a psychiatric setting.
8. The patient, if female, must:
- agree not to try to become pregnant during the study, AND
- use adequate contraception (adequate contraception is defined as oral/systemic
contraception, intrauterine device, diaphragm in combination with spermicide, or
condom for male partner in combination with spermicide), OR
- have had her last natural menstruation at least 24 months prior to baseline, OR
- have been surgically sterilised prior to baseline, OR
- have had a hysterectomy prior to baseline, OR
- not be sexually active
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A patient who meets one or more of the following criteria at the Screening Visit and/or at the Baseline Visit, is not eligible for inclusion in this study:
1. The patient has one or more of the following conditions:
- Any current psychiatric disorder established as the principal diagnosis other than
MDD as defined in the DSM-IV-TR (assessed by the MINI).
- Current or past history of: manic or hypomanic episode, schizophrenia or any other
psychotic disorder, including major depression with psychotic features, mental
retardation, organic mental disorders, or mental disorders due to a general medical
condition as defined in the DSM-IV-TR.
- Any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR.
- Presence or history of a clinically significant neurological disorder (including
epilepsy, stroke).
- Neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple
sclerosis, Huntington’s disease, etc.).
- Any axis II disorder that might compromise the study.
2. The patient, in the opinion of the investigator, has a significant risk of suicide, or has a score =5 on item 10 (suicidal thought) of the MADRS or has made a suicide attempt in the previous 6 months.
3. The current depressive symptoms of the patient are considered by the investigator to have been resistant to two or more adequate antidepressant treatments of at least 6 weeks duration.
4. The patient has used or uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant Medication), or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study.
5. The patient has received electroconvulsive therapy within 6 months prior to screening.
6. The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
7. The patient has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, skin and subcutaneous tissue disorders or metabolic disturbance.
8. The patient has a chronic liver disease.
9. The patient has clinically significant abnormal vital signs.
10. The patient has received venlafaxine as treatment for the current depressive episode.
11. The patient has a history of lack of response to previous adequate treatment with venlafaxine (including current episode).
12. The patient has a history of severe drug allergy or hypersensitivity, or known
hypersentivity to venlafaxine.
13. The patient has an identified very high risk of a serious cardiac ventricular arrhythmia (e.g. those with a significant left ventricular dysfunction, NYHA Class III/IV), uncontrolled hypertension or recent history of myocardial infarction.
14. The patient has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant.
15. The patient has TSH value outside the normal range at Screening Visit.
16. The patient has a clinically significant abnormal ECG.
17. The patient has a QTc interval on the ECG above 450 ms in accordance to the Fredericia method (QTc=QT/RR0.33), a history of long QT syndrome and/or a history of hypokalaemia.
18. The patient has a disease or takes medication that,
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with MDD;Secondary Objective: To evaluate the safety and tolerability of Lu AA34893 compared to placebo during the<br>course of treatment<br>To evaluate the population pharmacokinetic parameters of Lu AA34893 and relevant<br>metabolites;Primary end point(s): Based on FAS and observed cases (OC), the change from baseline in the MADRS total score up to week 8 will be analysed using a Mixed Model for Repeated Measurements (MMRM) with freely varying<br>covariance structures.
- Secondary Outcome Measures
Name Time Method