Major Depressive DisorderPhase 2NCT00226278
Safety Study of ORG 34517 for Major Depression With Psychotic Features
A Phase 2 study testing ORG 34517 in people with Major Depressive Disorder and Psychotic Disorders, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder, Psychotic Disorders
- What is being tested?
- ORG 34517
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Nov 2005
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial related activities
- be able to speak, read, understand, respond to questions and follow instructions in English
- have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes
- have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at screening and baseline
- have a PANSS Positive Scale score of at least 16 at screening and baseline
- have a total score of at least 18 on teh HAMD 17 item scale at Screening and Baseline
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- be on a stable dose of usual treatment which has to consist of an anti-depressant, an antipsychotic, a mood stabilizer or any combination of these three drug classes
- be 18 up to and including 70 years of age at Screening
- must be willing to be hospitalized for at least 11 days from Screening onwards.
Who cannot join
- have any other psychiatric diagnosis except MDD
- have a lifetime psychiatric diagnosis of Bipolar Disorder I, schizophrenia or schizoaffective disorders
- are at significant risk of committing suicide
- are currently treated with carbamazepine or valproate
- are currently treated with midazolam
- have been treated with electroconvulsive therapy in the current episode
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- are currently treated with more than one antidepressant
- are currently treated with more than one antipsychotic
- are currently treated with more than one mood stabilizer
- have usual treatment started or discontinued in the two weeks before randomization
- have a usual treatment dose change within the week prior to randomization
- have any clinically unstable or uncontrollable renal, hepatic, respiratory, haematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment efficacy
- have known hypersensitivity reactions to glucocorticoid antagonists
- have any clinically significant abnormal laboratory data
- have any untreated or uncompensated clinically significant endocrine disorder
- have a diagnosis or alcohol and/or drug dependence
- have a confirmed positive result on the drug screening test for any illicit drug except cannabis
- are using hormone replacement therapy at Screening
- require concomitant treatment with corticosteroids
- are subjects diagnosed with Cushing disease
- are women of childbearing potential without adequate contraception
- are women with a positive pregnancy test at screening or baseline or are breastfeeding mothers
- are male subjects with current diagnosis of prostrate hypertrophia or past history of symptoms of prostrate hypertrophia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York, 10021
About this study
Official title: Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"
Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. The patient will be hospitalized for up to two weeks to monitor their medications and progress and will return to the site for periodic assessments.
- Conditions
- Major Depressive Disorder, Psychotic Disorders
- Being tested
- ORG 34517
- Medical subject headings
- Depressive Disorder, Major, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ORG 34517Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionNov 2005
- Study completionNov 2005
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 Weill Medical College of Cornell UniversityThe 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
- Single group
- Masking
- Double blind
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Investigators
- James H Kocsis, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226278
- Sponsor's protocol ID
- 28130
- Status last verified
- Mar 2008
- First submitted
- 22 Sep 2005
- Last updated
- 31 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Double Blind, Randomized, Placebo-Controlled Dose Finding Study of the Efficacy and Safety of 2 Target Doses of Org 34517 Used as Adjunct"
- ClinicalTrials.gov ID
- NCT00226278
- Acronym / sponsor ID
- 28130
- Conditions
- Major Depressive Disorder, Psychotic Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 26 Sep 2005 (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.
Patients suffering from Major Depressive Disorder with Psychotic features who have received no changes in their medications in the previous two weeks will receive "usual" treatment of antidepressants, antipsychotics and/or mood stabilizers and adjunct therapy using ORG34517. The patient will be hospitalized for up to two weeks to monitor their medications and progress and will return to the site for periodic assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- provide voluntary written informed consent for trial participation after the scope and nature of the investigation have been explained to them, and before starting any trial related activities
- be able to speak, read, understand, respond to questions and follow instructions in English
- have a DSM-IV severe depressive episode with psychotic features, as diagnosed by the MINI for single or recurrent episodes
- have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at screening and baseline
- have a PANSS Positive Scale score of at least 16 at screening and baseline
Key exclusion criteria (23 listed)
- have any other psychiatric diagnosis except MDD
- have a lifetime psychiatric diagnosis of Bipolar Disorder I, schizophrenia or schizoaffective disorders
- are at significant risk of committing suicide
- are currently treated with carbamazepine or valproate
- are currently treated with midazolam
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 |
|---|---|---|
| ORG 34517 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
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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.
James H Kocsis, MD principal investigator
Weill Medical College of Cornell University
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 ORG 34517 in people with Major Depressive Disorder and Psychotic Disorders, run by Weill Medical College of Cornell University at 1 site 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 9 inclusion and 23 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: finished, as of the sponsor's last update on 31 Mar 2008. 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 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 31 Mar 2008.