SchizophreniaPhase 2GUESTNCT00988728
Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)
A Phase 2 study testing SCH 900435 (Org 25935) and Olanzapine in people with Schizophrenia, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- SCH 900435 (Org 25935) and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jul 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects eligible to participate:
- present a substantial and recent exacerbation of schizophrenia
- have responded positively to treatment with an antipsychotic other than clozapine in the past
- are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation
Who cannot join
- Schizoaffective disorder;
- single episode of schizophrenia in partial remission
- concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
- substance abuse or dependence (excluding nicotine and caffeine)
- uncompensated medical illness (including clinically relevant eye disorder)
About this study
Official title: A Multicenter, Randomized, Parallel-Group, Double-blind, Fixed-Dose, 28-Day Trial to Assess the Efficacy and Safety of SCH 900435 Compared With Placebo, Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (GUEST - Glycine Uptake Inhibitor Efficacy and Safety Trial, Phase 2, Protocol No. P06079)
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.
- Conditions
- Schizophrenia
- Being tested
- SCH 900435 (Org 25935), Placebo, Olanzapine
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCH 900435 (Org 25935)Drug
Oral tablets, containing 8 mg of active substance, two tablets (i.e. 16 mg) to be taken twice daily in the morning after breakfast and in the evening after dinner during 4 weeks.
Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with SCH 900435 plus 1 capsule with placebo per day).
PlaceboDrug
Oral capsules and tablets containing excipients only.
Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner.
OlanzapineDrug
Also called Zyprexa®
Oral capsules containing 15 mg of active substance, one capsule to be taken once daily after dinner for four weeks.
Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with placebo plus 1 capsule with olanzapine per day).
| Study group | Role | What they receive |
|---|---|---|
| SCH 900435 | Experimental | SCH 900435 (Org 25935): a Glycine Uptake Inhibitor Receives: Drug: SCH 900435 (Org 25935); Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Olanzapine | Active comparator | Not described Receives: Drug: Placebo; Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
Measured: 4 weeks (Day 28)
Secondary outcomes (1)
Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
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 posted2 Oct 2009 (estimated)
- Study startFeb 2011
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- 0 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
- NCT00988728
- Sponsor's protocol ID
- P06079
- Acronym
- GUEST
- Status last verified
- Dec 2015
- First submitted
- 1 Oct 2009
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-Group, Double-blind, Fixed-Dose, 28-Day Trial to Assess the Efficacy and Safety of SCH 900435 Compared With Placebo, Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (GUEST - Glycine Uptake Inhibitor Efficacy and Safety Trial, Phase 2, Protocol No. P06079)
- ClinicalTrials.gov ID
- NCT00988728
- Acronym / sponsor ID
- GUEST / P06079
- Conditions
- Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 2 Oct 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.
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCH 900435 | Experimental | Drug: SCH 900435 (Org 25935), Drug: PlaceboSCH 900435 (Org 25935): a Glycine Uptake Inhibitor |
| Placebo | Placebo comparator | Drug: Placebo |
| Olanzapine | Active comparator | Drug: Placebo, Drug: Olanzapine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects eligible to participate:
Key exclusion criteria (5 listed)
- Schizoaffective disorder;
- single episode of schizophrenia in partial remission
- concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
- substance abuse or dependence (excluding nicotine and caffeine)
- uncompensated medical illness (including clinically relevant eye disorder)
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 900435 (Org 25935)Oral tablets, containing 8 mg of active substance, two tablets (i.e. 16 mg) to be taken twice daily in the morning after breakfast and in the evening after dinner during 4 weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with SCH 900435 plus 1 capsule with placebo per day). | Drug | SCH 900435 |
| PlaceboOral capsules and tablets containing excipients only. Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner. | Drug | Olanzapine, Placebo, SCH 900435 |
| OlanzapineAlso: Zyprexa®Oral capsules containing 15 mg of active substance, one capsule to be taken once daily after dinner for four weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with placebo plus 1 capsule with olanzapine per day). | Drug | Olanzapine |
Primary outcome
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
Time frame: 4 weeks (Day 28)
1 secondary outcome
Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 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 SCH 900435 (Org 25935) and Olanzapine in people with Schizophrenia, 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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 17 Dec 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 was withdrawn before enrolling participants, so there are no results.
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?
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score) (time frame: 4 weeks (Day 28)). 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 17 Dec 2015.