Major Depressive DisorderPhase 2NCT00766870
Efficacy and Safety of Lu AA34893 in Patients With Major Depressive Disorder
A Phase 2 study testing Lu AA34893 and Venlafaxine extended release in people with Major Depressive Disorder, run by H. Lundbeck A/S at 1 site in Canada.
Trial summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Lu AA34893 and Venlafaxine extended release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Feb 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
- Moderate to severe depression
- Current MDE duration of at least 3 months
Who cannot join
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Females of childbearing potential and not using adequate contraception
- Use of any psychoactive medication within 2 weeks before randomisation and during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
Read the detailed description
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.
- Conditions
- Major Depressive Disorder
- Being tested
- Lu AA34893, Venlafaxine extended release, Placebo
- Keywords
- Efficacy, Safety, Depression, Interventional, Placebo, Short-term, Major Depressive Disorder, Major Depressive Episode
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AA34893Drug
Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period
Venlafaxine extended releaseDrug
Per oral, once daily, during 8 weeks, followed by a two-week tapering period
PlaceboDrug
Per oral doses, twice daily as capsules during 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Lu AA34893 |
| 2 | Experimental | Not described Receives: Drug: Lu AA34893 |
| 3 | Experimental | Not described Receives: Drug: Lu AA34893 |
| 4 | Other | Not described Receives: Drug: Venlafaxine extended release |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms as measured by the change from baseline in MADRS total score
Measured: 8 weeks
Secondary outcomes (1)
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2009
- Study completionFeb 2009
Why it stopped: Study was previously paused and is now terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766870
- Sponsor's protocol ID
- 12279A
- Other IDs
- 2007-007025-51
- Status last verified
- Sep 2010
- First submitted
- 3 Oct 2008
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00766870
- Acronym / sponsor ID
- 12279A
- Conditions
- Major Depressive Disorder
- Keywords
- Efficacy, Safety, Depression, Interventional, Placebo, Short-term, Major Depressive Disorder, Major Depressive Episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was previously paused and is now terminated
- Enrolment
- 35 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the efficacy, safety and tolerability of three fixed dosages of Lu AA34893 compared to placebo in the treatment of patients with Major Depressive Disorder.
Detailed description
Major Depressive Disorder (MDD) is reported to be the most common mood disorder, with a lifetime prevalence of about 15% and as high as 25% in women. MDD is characterised by the presence of one or more Major Depressive Episodes (MDEs) that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. MDD is a disabling, severe illness that tends to be chronic, and repeated episodes are common. Despite the availability of a range of effective treatments in MDD, a significant proportion of patients do not respond or achieve remission and many relapse despite continued treatment. Lu AA34893 has a novel mechanism of action and this could be of clinical relevance in addressing currently unmet needs in MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Lu AA34893 |
| 2 | Experimental | Drug: Lu AA34893 |
| 3 | Experimental | Drug: Lu AA34893 |
| 4 | Other | Drug: Venlafaxine extended release |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx)
- Moderate to severe depression
- Current MDE duration of at least 3 months
Key exclusion criteria (4 listed)
- Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
- Any substance disorder within the previous 6 months
- Females of childbearing potential and not using adequate contraception
- Use of any psychoactive medication within 2 weeks before randomisation and during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AA34893Per oral doses, divided in twice daily administrations as capsules during 8 weeks, followed by a two-week tapering period | Drug | 1, 2, 3 |
| Venlafaxine extended releasePer oral, once daily, during 8 weeks, followed by a two-week tapering period | Drug | 4 |
| PlaceboPer oral doses, twice daily as capsules during 10 weeks | Drug | 5 |
Primary outcome
Depressive symptoms as measured by the change from baseline in MADRS total score
Time frame: 8 weeks
1 secondary outcome
HAM-D, CGI, responders and remitters, HAM-A, adverse events, clinical safety laboratory tests, vital signs, weight, ECG, physical examination
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Study was previously paused and is now terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AA34893 and Venlafaxine extended release in people with Major Depressive Disorder, run by H. Lundbeck A/S at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study was previously paused and is now terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms as measured by the change from baseline in MADRS total score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2010.