DepressionPhase 2NCT01128452
Safety and Efficacy of EVT 101 in Treatment-Resistant Depression
A Phase 2 study testing EVT 101 in people with Depression, run by Janssen Research & Development, LLC at 14 sites in United States.
Trial summary
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depression
- What is being tested?
- EVT 101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2010to Mar 2011
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major Depressive Disorder
- Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
- Has as score of >/= 18 on the Ham-D-17
Who cannot join
- Pregnant or breast-feeding women
- Evidence of age-related cognitive decline or mild dementia
- At imminent risk of committing suicide
- Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
- Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
- Has had a substance or alcohol abuse or dependence disorder (except nicotine and caffeine) in the 1 year before screening
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Evotec Study Site 4
Atlanta, Georgia
Evotec Study Site 1
Baltimore, Maryland
Evotec Study Site 3
Beachwood, Illinois
Evotec Study Site 7
Dallas, Texas
Evotec Study Site 8
Flowood, Mississippi
Evotec Study Site 12
Houston, Texas
Evotec Study Site 9
New York, New York
Evotec Study Site 2
Oak Brook, Illinois
Evotec Study Site 6
Oceanside, California
Evotec Study Site 13
Oklahoma City, Oklahoma
Evotec Study Site 19
San Diego, California
Evotec Study Site 14
Smyrna, Georgia
Evotec Study Site 15
Tampa, Florida
Evotec Study Site 5
Willingboro, New Jersey
About this study
Official title: A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
- Conditions
- Depression
- Being tested
- EVT 101, Placebo
- Keywords
- Treatment-Resistant Depression
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVT 101Drug
HPMC Capsule, 15 mg, once daily for 28 days
PlaceboDrug
HPMC Placebo capsules, once daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| EVT 101 | Experimental | EVT 101 Receives: Drug: EVT 101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability Profile of EVT 101
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
Measured: 28 days of EVT 101-Treatment
Secondary outcomes (3)
Efficacy of EVT 101 in depression measured using the MADRS score
Efficacy of EVT 101 in depression measured using the MADRS score and comparing those scores at the end of treatment with scores at baseline
Measured: 28 days
Percentage of patients who respond to treatment with study drug
Measured: 4 weeks
Percentage of patients who experience remission
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Doris Greiling, PhD, Study director, Evotec AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128452
- Sponsor's protocol ID
- CR104589
- Other IDs
- RRA-12001, EVT 101/1012
- Status last verified
- Mar 2016
- First submitted
- 19 May 2010
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Safety and Efficacy of EVT 101 as Monotherapy in Patients With Treatment-Resistant Major Depression
- ClinicalTrials.gov ID
- NCT01128452
- Acronym / sponsor ID
- CR104589
- Conditions
- Depression
- Keywords
- Treatment-Resistant Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 21 May 2010 (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.
This study is a 4-week, randomized, double-blind, parallel-group, placebo-controlled monotherapy study in patients with treatment-resistant major depression. After confirmation of treatment-resistance in a prospective treatment period with citalopram, each patient will be treated with either EVT 101 once daily or placebo for 28 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| EVT 101 | Experimental | Drug: EVT 101EVT 101 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major Depressive Disorder
- Current episode of major depression that has not benefited from at least 1 but no more than 3 adequate treatment regimens
- Has as score of >/= 18 on the Ham-D-17
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding women
- Evidence of age-related cognitive decline or mild dementia
- At imminent risk of committing suicide
- Has with the exception of major depression, a serious medical or neurological illness, including seizure disorder, stroke, dementia, or Parkinson disease
- Has an established diagnosis of bipolar disorder, hypomania, schizoaffective disorder, major depression with psychotic features or schizophrenia
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 |
|---|---|---|
| EVT 101HPMC Capsule, 15 mg, once daily for 28 days | Drug | EVT 101 |
| PlaceboHPMC Placebo capsules, once daily for 28 days | Drug | Placebo |
Primary outcome
Safety and Tolerability Profile of EVT 101
Time frame: 28 days of EVT 101-Treatment
AE monitoring, clinical laboratory assessments, vital sign measurements, body weight, 12-lead ECG, physical exmaninations, ophthalmological examinations and questionnaires
3 secondary outcomes
Efficacy of EVT 101 in depression measured using the MADRS score
Time frame: 28 days
Percentage of patients who respond to treatment with study drug
Time frame: 4 weeks
Percentage of patients who experience remission
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
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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.
Doris Greiling, PhD study director
Evotec AG
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EVT 101 in people with Depression, run by Janssen Research & Development, LLC at 14 sites in United States.
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 6 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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. 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: Evotec has indicated that this study was discontinued due to a clinical hold issued by the FDA). 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?
Safety and Tolerability Profile of EVT 101 (time frame: 28 days of EVT 101-Treatment). 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 28 Mar 2016.