Depressive DisordersPhase 2NCT00844922

Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842)

A Phase 2 study testing SCH 900636 in people with Depressive Disorders and Psychotic Disorders, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Patients who participated in the previous trial 28130, who were eligible, were entered into this trial. Patients who were randomized to placebo in the previous trial 28130 continued on placebo while patients who were randomized to Org 34517 (SCH 900636), regardless of dose, were titrated to 900 mg Org 34517. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Depressive Disorders, Psychotic Disorders, Depression
What is being tested?: SCH 900636
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 16 participants
Where: No sites listed yet
Study dates: Sep 2005to Jun 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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130;
have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted;
be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.

Who cannot join

had experienced any of the following significant safety outcomes in previous trial 28130:
severe breakthrough bleeding;
diagnosis of prostatitis;
abnormal level of testosterone at Day 15 of previous trial 28130;
any adverse event deemed relevant for exclusion in trial 28133 by the investigator.
had an abnormal PSA test at Day -7 of previous trial 28133

Show all 21Show fewer

were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
were currently treated with carbamazepine or valproate, midazolam, or clozapine;
had been treated with electroconvulsive therapy (ECT) in the current episode;
were currently treated with more than one antidepressant, antipsychotic, or mood stabilizer;
had 'usual treatment' started or discontinued in the 2 weeks before Day 1;
had a 'usual treatment' dose change within one week prior to Day 1;
had 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;
had known hypersensitivity reactions to glucocorticoid antagonists;
had 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 Day -7;
had a confirmed positive result on the drug screening test for any illicit drug, except cannabis, at Day -7;
had any untreated or uncompensated clinically significant endocrine disorder;
were using hormone replacement therapy at Day -7;
required concomitant treatment with corticosteroids (topical use was allowed);
women of childbearing potential without adequate contraception
women with a positive pregnancy test at Day -7 or 1, or are breast feeding mothers.

About this study

Official title: Double-blind, Placebo-controlled Trial Investigating the Safety of Re-exposure to 900 mg of Org 34517, Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features), Who Participated in Trial 28130

Conditions: Depressive Disorders, Psychotic Disorders, Depression
Being tested: SCH 900636, Placebo
Medical subject headings: Depressive Disorder, Psychotic Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCH 900636Drug
Also called Org 34517
Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.
PlaceboDrug
Placebo

Study groups in NCT00844922
Study group	Role	What they receive
Org 34517	Experimental	Org 34517 titrated to 900 mg daily for 2 weeks Receives: Drug: SCH 900636
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.

Safety and tolerability measures (vital signs, AEs)
Measured: 4 weeks

Secondary outcomes (6)

17-item Hamilton Rating Scale for Depression (HAMD) total score
Measured: 4 weeks
proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response
Measured: 4 weeks
proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response
Measured: 4 weeks
clinical global impression (CGI)
Measured: 4 weeks
PANNS total score
Measured: 4 weeks
PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2005Jun 2006

First posted16 Feb 2009 (estimated)
Study startSep 2005
Primary completionJun 2006
Study completionJun 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Depressive DisordersStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00844922
Sponsor's protocol ID: P05842
Other IDs: EudraCT #: 2004-002156-34;, P05842
Status last verified: Dec 2014
First submitted: 11 Feb 2009
Last updated: 31 Dec 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

All Depressive Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Double-blind, Placebo-controlled Trial Investigating the Safety of Re-exposure to 900 mg of Org 34517, Used as Adjunctive Therapy in Subjects With Psychotic Major Depression (Major Depressive Episode, Severe, With Psychotic Features), Who Participated in Trial 28130
ClinicalTrials.gov ID: NCT00844922
Acronym / sponsor ID: P05842
Conditions: Depressive Disorders, Psychotic Disorders, Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Jun 2006 (actual)
Study completion: Jun 2006 (actual)
First posted: 16 Feb 2009 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Org 34517	Experimental	Drug: SCH 900636Org 34517 titrated to 900 mg daily for 2 weeks
Placebo	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)

have attended Screening, Baseline, Visit Day 15, Day 29 and Day 43 of previous trial 28130;
have a CGI of Severity score of 3 or greater at Day 43 of previous trial 28130 and at Day 1 of current trial 28133, or a lower score when the investigator is of the opinion that further resolution of symptoms is warranted;
be on a stable dose of 'usual treatment', which must consist of an antidepressant, an antipsychotic, a mood stabilizer or any combination of these 3 drug classes.

Key exclusion criteria (21 listed)

had experienced any of the following significant safety outcomes in previous trial 28130:
had an abnormal PSA test at Day -7 of previous trial 28133
were at significant risk of committing suicide, as indicated by a score greater than 9 on the revised ISST at Day -7 or Day 1;
were currently treated with carbamazepine or valproate, midazolam, or clozapine;
had been treated with electroconvulsive therapy (ECT) in the current episode;

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
SCH 900636Also: Org 34517Org 34517 300 mg on Day 1, 600 mg on Day 2, then 900 mg daily starting from Day 3. Subjects in this arm were also to continue the "usual treatment" for psychotic major depression.	Drug	Org 34517
PlaceboPlacebo	Drug	Placebo

Primary outcome

Safety and tolerability measures (vital signs, AEs)
Time frame: 4 weeks

6 secondary outcomes

17-item Hamilton Rating Scale for Depression (HAMD) total score
Time frame: 4 weeks
proportion of BPRS 30% responders; proportion of subjects with sustained BPRS 30% response
Time frame: 4 weeks
proportion of HAMD 50% responders; proportion of subjects with sustained HAMD 50% response
Time frame: 4 weeks
clinical global impression (CGI)
Time frame: 4 weeks
PANNS total score
Time frame: 4 weeks
PANSS positive scale score, PANSS negative scale score, PANSS general psychopathology score
Time frame: 4 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 31 Dec 2014.

Related trials for Depressive Disorders

Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety

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 SCH 900636 in people with Depressive Disorders and Psychotic 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 3 inclusion and 21 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 Dec 2014. 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?

Safety and tolerability measures (vital signs, AEs) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00844922.

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 Dec 2014.