DepressionPhase 2HermesNCT00212797
A Study to Determine the Efficacy and Safety of 2 Doses of Org 34517 as Adjunctive Therapy in Subjects With Psychotic Major Depression (28130)(P05845)
A Phase 2 study testing Org 34517 in people with Depression and Depressive Disorders, run by Merck Sharp & Dohme LLC.
Trial summary
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depression, Depressive Disorders, Psychotic Disorders
- What is being tested?
- Org 34517
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 273 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Jul 2006
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening);
- be able to speak, read, understand, respond to questions, and follow
- instructions in English or their native language;
- have DSM-IV severe depressive episode with psychotic features, as
- diagnosed by the MINI for single or recurrent episodes (296.24 or 296.34);
- have a score on PANSS item "Delusions" AND/OR "Hallucinatory behavior" of at least 4 at Screening and Baseline;
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- have a PANSS Positive Scale score of at least 16 at Screening and Baseline;
- have a total score of at least 18 on the HAMD 17-item scale at Screening and Baseline;
- be on a stable dose of "usual treatment", which had to consist of an
- antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes;
- be between 18 and 75 years of age (inclusive) at Screening;
- be willing to be hospitalized for at least 11 days from Screening onwards.
Who cannot join
- have any other current psychiatric diagnosis (according to the MINI) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
- have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode;
- be at significant risk of committing suicide, as indicated by a score greater than 9 on the revised InterSePT Scale for Suicidal Thinking (ISST);
- be currently treated with carbamazepine or valproate;
- be currently treated with midazolam;
- be treated with electroconvulsive therapy in the current episode;
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- be currently treated with more than one antidepressant;
- be currently treated with more than one antipsychotic;
- be currently treated with more than one mood stabilizer;
- have a "usual treatment" started or discontinued in the 2 weeks before
- Randomization;
- have a "usual treatment" dose change within the week prior to
- Randomization;
- have any clinically unstable or uncontrollable renal, hepatic, respiratory,
- hematological, cardiovascular or cerebrovascular disease that would put the patient at risk of safety or bias assessment of efficacy;
- have known hypersensitivity reactions to glucocorticoid antagonists;
- have any clinically significant abnormal laboratory data (e.g. aspartate amino transferase (ASAT) and/or alanine amino transferase (ALAT) values > 2x normal range upper limit) or ECG results, or a clinically significant abnormal outcome at the physical examination at the screening visit;
- have any untreated or uncompensated clinically significant endocrine
- disorder;
- have a MINI diagnosis of alcohol and/or drug dependence;
- have a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Screening;
- be using hormone replacement therapy at Screening;
- have required concomitant treatment with corticosteroids, like
- dexamethasone, prednisone or cortisol (topical use is allowed);
- be diagnosed with Cushing's disease;
- be women of childbearing potential without adequate contraception;
- be women with a positive pregnancy test at Screening or Baseline, or
- breastfeeding mothers;
- be males with a current diagnosis of prostate hypertrophia or past history (less than 3 months) of symptoms of prostate hypertrophia.
- be currently treated with clozapine (per Amendment III);
- be currently treated with systemic or topical ketaconazole.
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 Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features).
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.
Read the detailed description
Major depression with psychotic features (psychotic depression) is the most debilitating disorder in the depressive disorders spectrum. It is associated with severe symptoms, prolonged course, poorer response rates, more residual symptoms, more frequent relapses and higher mortality, as compared to major depressive disorder.
The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression.
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.
- Conditions
- Depression, Depressive Disorders, Psychotic Disorders
- Being tested
- Org 34517, Placebo
- Medical subject headings
- Depression, Depressive Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Org 34517Drug
low dose Org 34517
Org 34517Drug
high dose Org 34517
PlaceboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Org 34517_1 | Experimental | low dose Org 34517 Receives: Drug: Org 34517 |
| Org 34517_2 | Experimental | high dose Org 34517 Receives: Drug: Org 34517 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS positive symptoms subscale.
Measured: 6 weeks
Secondary outcomes (1)
Ham-D17, CGI, Cognition, spermatogenesis
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2004
- Primary completionJul 2006
- Study completionJul 2006
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 Merck Sharp & Dohme 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212797
- Sponsor's protocol ID
- P05845
- Other IDs
- Protocol 28130
- Acronym
- Hermes
- Status last verified
- Nov 2015
- First submitted
- 15 Sep 2005
- Last updated
- 26 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2015. 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 Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features).
- ClinicalTrials.gov ID
- NCT00212797
- Acronym / sponsor ID
- Hermes / P05845
- Conditions
- Depression, Depressive Disorders, Psychotic Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 21 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.
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.
Detailed description
Major depression with psychotic features (psychotic depression) is the most debilitating disorder in the depressive disorders spectrum. It is associated with severe symptoms, prolonged course, poorer response rates, more residual symptoms, more frequent relapses and higher mortality, as compared to major depressive disorder.
The markedly abnormal HPA axis functioning in psychotic depression has encouraged research to investigate whether the HPA axis would be a target for pharmacotherapy in depression.
The primary purpose of this study is to determine whether subjects with psychotic major depression benefit from adjunctive treatment with GR antagonist Org 34517. Two doses of Org 34517 will be compared to placebo in this international multicenter study. The duration of this trial is 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Org 34517_1 | Experimental | Drug: Org 34517low dose Org 34517 |
| Org 34517_2 | Experimental | Drug: Org 34517high dose Org 34517 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- have provided voluntary written informed consent for trial participation after the scope and nature of the investigation were explained to them, and before starting any trial-related activities (before Screening);
- be able to speak, read, understand, respond to questions, and follow
- instructions in English or their native language;
- have DSM-IV severe depressive episode with psychotic features, as
- diagnosed by the MINI for single or recurrent episodes (296.24 or 296.34);
Key exclusion criteria (31 listed)
- have any other current psychiatric diagnosis (according to the MINI) except MDD, such as organic mental syndromes and disorders, delirium or anxiety disorders;
- have a lifetime psychiatric diagnosis of psychotic disorders (according to the MINI), or a MINI diagnosis of past manic episode;
- be at significant risk of committing suicide, as indicated by a score greater than 9 on the revised InterSePT Scale for Suicidal Thinking (ISST);
- be currently treated with carbamazepine or valproate;
- be 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 34517low dose Org 34517 | Drug | Org 34517_1 |
| Org 34517high dose Org 34517 | Drug | Org 34517_2 |
| Placeboplacebo | Drug | Placebo |
Primary outcome
PANSS positive symptoms subscale.
Time frame: 6 weeks
1 secondary outcome
Ham-D17, CGI, Cognition, spermatogenesis
Time frame: 6 weeks
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 26 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Org 34517 in people with Depression and Depressive Disorders, run by Merck Sharp & Dohme LLC.
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 12 inclusion and 31 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 26 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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.
What does the primary outcome measure?
PANSS positive symptoms subscale. (time frame: 6 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 26 Nov 2015.