SchizophreniaPhase 1NCT02901587
Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
A Phase 1 study testing Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day) and Quetiapine (Seroquel XR® 800 mg/day) in people with Schizophrenia and Schizoaffective Disorder, run by H. Lundbeck A/S at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day) and Quetiapine (Seroquel XR® 800 mg/day)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 18 Apr 2018
- Phase
- Phase 1
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient is able by her/himself to provide informed consent to participate in the study
- The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
- The patient has BMI ≤35 kg/m2
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
- PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
- The patient is willing to be hospitalized for up to 8 weeks
- The patient is generally healthy based on medical history, physical examination, vital signs, ECG, and laboratory tests.
- The patient agrees to protocol-defined use of effective contraception
Who cannot join
- The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
- The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
- The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
- The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- Other protocol defined inclusion and exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
The purpose of this study is to investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day), Quetiapine (Seroquel XR® 800 mg/day)
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AF35700 (10 mg/day)Drug
tablets for oral administration once daily
Lu AF35700 (30 mg/day)Drug
tablets for oral administration once daily
Quetiapine (Seroquel XR® 800 mg/day)Drug
tablets for oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| Lu AF35700 (10 mg/day) | Experimental | Lu AF35700 10 mg/day for 6 weeks Receives: Drug: Lu AF35700 (10 mg/day) |
| Lu AF35700 (30 mg/day) | Experimental | Lu AF35700 30 mg/day for 6 weeks Receives: Drug: Lu AF35700 (30 mg/day) |
| Quetiapine (Seroquel XR® 800 mg/day) | Experimental | Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks Receives: Drug: Quetiapine (Seroquel XR® 800 mg/day) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from time-matched baseline on day 1, 21, and 42 in QTcF
Measured: Before dose to 10 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
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 H. Lundbeck A/SThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, LundbeckClinicalTrials@Lundbeck.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901587
- Sponsor's protocol ID
- 16323A
- Status last verified
- Sep 2019
- First submitted
- 12 Sep 2016
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT02901587
- Acronym / sponsor ID
- 16323A
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 15 Sep 2016 (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 investigate the effect of Lu AF35700 on electrical activity in the heart as measured on an electrocardiogram (ECG) in patients with schizophrenia or schizoaffective disorder after 6 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lu AF35700 (10 mg/day) | Experimental | Drug: Lu AF35700 (10 mg/day)Lu AF35700 10 mg/day for 6 weeks |
| Lu AF35700 (30 mg/day) | Experimental | Drug: Lu AF35700 (30 mg/day)Lu AF35700 30 mg/day for 6 weeks |
| Quetiapine (Seroquel XR® 800 mg/day) | Experimental | Drug: Quetiapine (Seroquel XR® 800 mg/day)Quetiapine (Seroquel XR®) 800 mg/day for 6 weeks |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- The patient is able by her/himself to provide informed consent to participate in the study
- The patient has a primary diagnosis of schizophrenia or schizoaffective disorder (DSM-5™ criteria)
- The patient has BMI ≤35 kg/m2
- The patient has a Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill)
- PANSS total score ≤ 80 and a score ≤4 (moderate) on the PANSS items, P7 (hostility) and G8 (uncooperativeness)
Key exclusion criteria (5 listed)
- The patient experienced acute exacerbation of psychosis requiring hospitalization within the last 3 months or required change in medication due to exacerbation of psychosis within the last 8 weeks
- The patient has met moderate or severe co-morbid Substance Abuse Disorder DSM-5™ criteria in the last 3 months
- The patient is at significant risk of harming her/himself or others in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS)
- The patient has tested positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV)
- Other protocol defined inclusion and exclusion criteria may apply
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 |
|---|---|---|
| Lu AF35700 (10 mg/day)tablets for oral administration once daily | Drug | Lu AF35700 (10 mg/day) |
| Lu AF35700 (30 mg/day)tablets for oral administration once daily | Drug | Lu AF35700 (30 mg/day) |
| Quetiapine (Seroquel XR® 800 mg/day)tablets for oral administration once daily | Drug | Quetiapine (Seroquel XR® 800 mg/day) |
Primary outcome
Change from time-matched baseline on day 1, 21, and 42 in QTcF
Time frame: Before dose to 10 hours post dose
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 12 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Email contact via H. Lundbeck A/S study director
LundbeckClinicalTrials@Lundbeck.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu AF35700 (10 mg/day), Lu AF35700 (30 mg/day) and Quetiapine (Seroquel XR® 800 mg/day) in people with Schizophrenia and Schizoaffective Disorder, run by H. Lundbeck A/S 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 8 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: finished, as of the sponsor's last update on 12 Sep 2019. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Change from time-matched baseline on day 1, 21, and 42 in QTcF (time frame: Before dose to 10 hours post dose). 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 12 Sep 2019.