Dose-finding Study With Lu AA24530 in Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 21 November 2016
• Main ID: NCT00599911
• Date of registration: 28/12/2007
• Prospective Registration: No
• Primary sponsor: H. Lundbeck A/S
• Public title: Dose-finding Study With Lu AA24530 in Major Depressive Disorder
• Scientific title: Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-referenced, Dose-finding Study of Lu AA24530 in Major Depressive Disorder
• Date of first enrolment: October 2007
• Target sample size: 652
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00599911
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Australia, Austria, Belgium, Canada, Czech Republic, Finland, France, India, Korea, Republic of, Lithuania, Malaysia, Norway, Philippines, Russian Federation, Serbia, Sweden, Ukraine

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

Inclusion Criteria:

- Major Depressive Episode that has lasted at least 3 months

- Moderate to severe depression

Exclusion Criteria:

- Any current psychiatric disorder established as the principal diagnosis other than
MDD as defined in the DSM-IV-TR and as assessed with the Mini-International
Neuropsychiatric Interview (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

- Major Depressive Episode that has been unresponsive to two adequate courses of
antidepressant treatment, each of at least 6 weeks duration

- Electroconvulsive therapy within 6 months prior to Baseline

- Ongoing formal cognitive or behavioural therapy, systematic psychotherapy, or plans
to initiate such therapy during the study

- Clinically significant unstable illness, for example, hepatic or renal insufficiency,
or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological,
infectious, neoplastic, or metabolic disturbance

- The patient is pregnant or breast-feeding



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Placebo

Drug: Lu AA24530

Drug: Duloxetine

Primary Outcome(s)

The difference in change from baseline to end of treatment on the Montgomery-Åsberg Depression Rating Scale total score [Time Frame: 6 weeks]

Secondary Outcome(s)

Response rate, remission rate, and safety [Time Frame: 6 weeks]

Secondary ID(s)

2007-001071-11

11918A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors