SchizophreniaPhase 1NCT02824055

A Study to Evaluate The Effects of RO5545965 in Participants With Negative Symptoms of Schizophrenia Treated With Antipsychotics

A Phase 1 study testing RO5545965 in people with Schizophrenia, run by Hoffmann-La Roche at 3 sites in United States.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Schizophrenia
What is being tested?: RO5545965
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 33 participants
Where: 3 sitesUnited States
Study dates: 27 Jun 2016to 24 Apr 2017
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 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A diagnostic and statistical manual of mental disorders-5 (DSM-5) diagnosis of schizophrenia as established by structured clinical interview for DSM-5-clinical trial (SCID-5-CT) at screening
Participants with no hospitalization for worsening of schizophrenia within 3 months prior to screening
Male and female participants with no childbearing capacity; females must be either surgically sterile or postmenopausal for at least 1 year
Body mass index (BMI) greater than (>) 18.5 kilograms per square meter (kg/m^2) and less than (<) 35 kg/m^2
Fluent in English, even if English is not the primary language
Participants with clinical global impression-severity (CGI-S) score greater than or equal to (>/=) 3 (mildly ill)

Show all 10Show fewer

Participants with a score of less than or equal to (</=) 4 (moderate) on positive and negative syndrome scale (PANSS) items P7 (hostility), G8 (uncooperativeness) and G6 (depression)
Participants with PANSS negative symptom factor score >/=18
Participants with calgary depression rating scale for schizophrenia (CDSS) score </=8
Participants on stable treatment, that is 6 weeks without change, with no more than two antipsychotics prior to screening

Who cannot join

Moderate to severe substance use disorder within 6 months as defined by DSM-5
Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cannabinoids, cocaine and barbiturates
Participants at significant risk of suicide or harming him or herself or others according to the Investigator's judgment
History of neuroleptic malignant syndrome
A prior or current general medical condition that might be impairing cognition or other psychiatric functioning
A movement disorder due to antipsychotic treatment not currently controlled with anti-extrapyramidal symptoms (anti-EPS) treatment or another movement disorder which might affect the ratings on the EPS scales

Show all 20Show fewer

Participants with a score >2 (mild) in any of the four CGI-S items of the extrapyramidal symptom rating scale (ESRS-A)
History of human immunodeficiency virus (HIV) infection, Hepatitis B, or Hepatitis C infection
QTcF interval >450 milliseconds (msec) (470 msec for females) or other significant abnormality on screening electrocardiogram (ECG) based on centralized reading
Clinically significant abnormalities in laboratory safety test results
Significant or unstable physical condition
Receipt of an investigational drug within 90 days or 5 times the half-life of the investigational drug, whatever is longer, prior to screening
Previously received RO5545965
Electroconvulsive treatment (ECT) within 6 months prior to screening
Current or 6 months prior to screening treatment with olanzapine or clozapine
Change in benzodiazepine or sleep medication regimen within 2 weeks prior to screening
Change in anti-EPS medication within two weeks prior to screening
Use of prohibited medications taken within 14 days or within 5 times the elimination half-life of the medication before the first study drug administration
Use of any strong or moderate inhibitor of cytochrome P 450 3A (CYP3A) or CYP2C8 and any inducer of CYP3A within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration
Use of any other nutrients known to modulate CYP3A activity within 1 week before the first study drug administration

Trial locations and contacts

3 sites in 1 country.

United States3 sites

CNS Network
Garden Grove, California, 92845
Parexel California Clinical Trials Medical Group
Glendale, California, 91206
St Louis Clinical Trials
St Louis, Missouri, 63141

Other trials in United States

About this study

This is a multicenter, randomized, double-blind, placebo-controlled, three period crossover study to evaluate the effects of RO5545965 on the functioning of key brain circuitry involved in negative symptoms using functional magnetic resonance imaging (fMRI) and reward-based learning in stable participants with mild to moderate negative symptoms of schizophrenia treated with antipsychotics. Participants will be randomized to one of six different sequences during which each participant will receive three 3-week treatment courses with RO5545965 5 milligrams (mg), RO5545965 15 mg and placebo. Each treatment period will be separated by a washout period of 14 days. Total duration of study will be approximately 17 weeks.

Conditions: Schizophrenia
Being tested: Placebo, RO5545965
Medical subject headings: Schizophrenia

What participants receive

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

PlaceboDrug
Participants will receive placebo matched to RO5545965 capsules orally daily in any of the three intervention period.
RO5545965Drug
Participants will receive RO5545965 5 mg capsules or RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily in any of the three intervention period.

Study groups in NCT02824055
Study group	Role	What they receive
Placebo first; then RO5545965 15 mg; then RO5545965 5mg	Placebo comparator	Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965
Placebo first; then RO5545965 5 mg; then RO5545965 15 mg	Placebo comparator	Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965
RO5545965 15 mg first; then Placebo; then RO5545965 5 mg	Experimental	Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965
RO5545965 15 mg first; then RO5545965 5 mg; then Placebo	Experimental	Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965
RO5545965 5 mg first; then Placebo; then RO5545965 15 mg	Experimental	Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965
RO5545965 5 mg first; then RO5545965 15 mg; then Placebo	Experimental	Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period. Receives: Drug: Placebo; Drug: RO5545965

What is being measured

The primary outcome is the main question the study is designed to answer.

Apparent volume of distribution (Vz/F)
Measured: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Activity of the ventral striatum during reward expectation in a monetary incentive delay fMRI task as measured by blood oxygen level dependent (BOLD) activity
Measured: Baseline (Day 1) up to end of study (up to 17 weeks)
Performance in reward based learning tasks as measured by the working memory reinforcement learning task
Measured: Day 22 up to Day 92
Performance in reward based learning tasks as measured by the effort cost/benefit tradeoff task
Measured: Day 22 up to Day 92
Apparent oral clearance (CL/F)
Measured: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85

Secondary outcomes (12)

Activity in the dorsolateral prefrontal cortex in the N-back working memory task as measured by BOLD activity
Measured: Baseline (Day 1) up to end of study (up to 17 weeks)
Cerebral blood flow in key brain areas (ventral striatum, orbitofrontal cortex) implicated in the etiology of negative symptoms as measured by arterial spin labeling (ASL)
Measured: Baseline (Day 1) up to end of study (up to 17 weeks)
Overall symptoms score of schizophrenia based on total PANSS
Measured: Baseline (Day 1), Days 22, 57, and 92
Symptom domains of schizophrenia based on PANSS factor subscales
Measured: Baseline (Day 1), Days 22, 57, and 92
Negative symptoms score of schizophrenia based on brief negative symptom scale (BNSS)
Measured: Baseline (Day 1), Days 22, 57, and 92
Overall clinical status based on CGI-S scores
Measured: Baseline (Day 1), Days 22, 57, and 92
Overall clinical status based on CGI-Improvement (CGI-I) score
Measured: Baseline (Day 1), Days 22, 57, and 92
Overall global impression of negative symptoms based on CGI-S negative symptoms
Measured: Baseline (Day 1), Days 22, 57, and 92
Overall global impression of negative symptoms based on CGI-I negative symptoms
Measured: Baseline (Day 1), Days 22, 57, and 92
Area under the concentration-time curve (AUC)
Measured: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Maximum observed plasma concentration (Cmax)
Measured: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Measured: Screening (Day -15 to Day -1) up to end of study (up to 17 weeks)

Timeline

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

27 Jun 201624 Apr 2017

First posted6 Jul 2016 (estimated)
Study start27 Jun 2016
Primary completion24 Apr 2017
Study completion24 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe 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: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02824055
Sponsor's protocol ID: BP29904
Status last verified: Jun 2017
First submitted: 21 Jun 2016
Last updated: 7 Jun 2017
Results posted: No

Publications

Omlor W, Cecere G, Huang GY, Spiller T, Misra AR, Rabe F, Kallen N, Kirschner M, Surbeck W, Burrer A, Garibaldi G, Holiga S, Dukart J, Umbricht D, Homan P. Exploratory analysis of the relationship between striatal connectivity and apathy during phosphodiesterase 10 inhibition in schizophrenia: findings from a randomized crossover trial. BMC Med. 2025 Mar 28;23(1):187. doi: 10.1186/s12916-025-04004-2.
PubMed 40155941
Umbricht D, Cheng WY, Lipsmeier F, Bamdadian A, Lindemann M. Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms. Front Psychiatry. 2020 Sep 16;11:574375. doi: 10.3389/fpsyt.2020.574375. eCollection 2020.
PubMed 33192706

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?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate The Effects of RO5545965 in Participants With Negative Symptoms of Schizophrenia Treated With Antipsychotics
ClinicalTrials.gov ID: NCT02824055
Acronym / sponsor ID: BP29904
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: 27 Jun 2016 (actual)
Primary completion: 24 Apr 2017 (actual)
Study completion: 24 Apr 2017 (actual)
First posted: 6 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Placebo first; then RO5545965 15 mg; then RO5545965 5mg	Placebo comparator	Drug: Placebo, Drug: RO5545965Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.
Placebo first; then RO5545965 5 mg; then RO5545965 15 mg	Placebo comparator	Drug: Placebo, Drug: RO5545965Participants will receive placebo matched to RO5545965 capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.
RO5545965 15 mg first; then Placebo; then RO5545965 5 mg	Experimental	Drug: Placebo, Drug: RO5545965Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 5 mg capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.
RO5545965 15 mg first; then RO5545965 5 mg; then Placebo	Experimental	Drug: Placebo, Drug: RO5545965Participants will receive RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 5 mg capsules orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.
RO5545965 5 mg first; then Placebo; then RO5545965 15 mg	Experimental	Drug: Placebo, Drug: RO5545965Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then placebo matched to RO5545965 capsules orally daily from Weeks 6 to 8 in second intervention period; followed by RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.
RO5545965 5 mg first; then RO5545965 15 mg; then Placebo	Experimental	Drug: Placebo, Drug: RO5545965Participants will receive RO5545965 5 mg capsules orally daily from Weeks 1 to 3 in first intervention period; then RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily from Weeks 6 to 8 in second intervention period; followed by placebo matched to RO5545965 capsules orally daily from Weeks 11 to 13 in third intervention period. A washout period of minimum 14 days will be maintained between each period.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

A diagnostic and statistical manual of mental disorders-5 (DSM-5) diagnosis of schizophrenia as established by structured clinical interview for DSM-5-clinical trial (SCID-5-CT) at screening
Participants with no hospitalization for worsening of schizophrenia within 3 months prior to screening
Male and female participants with no childbearing capacity; females must be either surgically sterile or postmenopausal for at least 1 year
Body mass index (BMI) greater than (>) 18.5 kilograms per square meter (kg/m^2) and less than (<) 35 kg/m^2
Fluent in English, even if English is not the primary language

Key exclusion criteria (20 listed)

Moderate to severe substance use disorder within 6 months as defined by DSM-5
Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenorphine, methadone, cannabinoids, cocaine and barbiturates
Participants at significant risk of suicide or harming him or herself or others according to the Investigator's judgment
History of neuroleptic malignant syndrome
A prior or current general medical condition that might be impairing cognition or other psychiatric functioning

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
PlaceboParticipants will receive placebo matched to RO5545965 capsules orally daily in any of the three intervention period.	Drug	Placebo first; then RO5545965 15 mg; then RO5545965 5mg, Placebo first; then RO5545965 5 mg; then RO5545965 15 mg, RO5545965 15 mg first; then Placebo; then RO5545965 5 mg, RO5545965 15 mg first; then RO5545965 5 mg; then Placebo, RO5545965 5 mg first; then Placebo; then RO5545965 15 mg, RO5545965 5 mg first; then RO5545965 15 mg; then Placebo
RO5545965Participants will receive RO5545965 5 mg capsules or RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily in any of the three intervention period.	Drug	Placebo first; then RO5545965 15 mg; then RO5545965 5mg, Placebo first; then RO5545965 5 mg; then RO5545965 15 mg, RO5545965 15 mg first; then Placebo; then RO5545965 5 mg, RO5545965 15 mg first; then RO5545965 5 mg; then Placebo, RO5545965 5 mg first; then Placebo; then RO5545965 15 mg, RO5545965 5 mg first; then RO5545965 15 mg; then Placebo

Primary outcome

Apparent volume of distribution (Vz/F)
Time frame: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Activity of the ventral striatum during reward expectation in a monetary incentive delay fMRI task as measured by blood oxygen level dependent (BOLD) activity
Time frame: Baseline (Day 1) up to end of study (up to 17 weeks)
Performance in reward based learning tasks as measured by the working memory reinforcement learning task
Time frame: Day 22 up to Day 92
Performance in reward based learning tasks as measured by the effort cost/benefit tradeoff task
Time frame: Day 22 up to Day 92
Apparent oral clearance (CL/F)
Time frame: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85

12 secondary outcomes

Activity in the dorsolateral prefrontal cortex in the N-back working memory task as measured by BOLD activity
Time frame: Baseline (Day 1) up to end of study (up to 17 weeks)
Cerebral blood flow in key brain areas (ventral striatum, orbitofrontal cortex) implicated in the etiology of negative symptoms as measured by arterial spin labeling (ASL)
Time frame: Baseline (Day 1) up to end of study (up to 17 weeks)
Overall symptoms score of schizophrenia based on total PANSS
Time frame: Baseline (Day 1), Days 22, 57, and 92
Symptom domains of schizophrenia based on PANSS factor subscales
Time frame: Baseline (Day 1), Days 22, 57, and 92
Negative symptoms score of schizophrenia based on brief negative symptom scale (BNSS)
Time frame: Baseline (Day 1), Days 22, 57, and 92
Overall clinical status based on CGI-S scores
Time frame: Baseline (Day 1), Days 22, 57, and 92
Overall clinical status based on CGI-Improvement (CGI-I) score
Time frame: Baseline (Day 1), Days 22, 57, and 92
Overall global impression of negative symptoms based on CGI-S negative symptoms
Time frame: Baseline (Day 1), Days 22, 57, and 92
Overall global impression of negative symptoms based on CGI-I negative symptoms
Time frame: Baseline (Day 1), Days 22, 57, and 92
Area under the concentration-time curve (AUC)
Time frame: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Maximum observed plasma concentration (Cmax)
Time frame: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Time frame: Screening (Day -15 to Day -1) up to end of study (up to 17 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 7 Jun 2017.
Derived from this study: PubMed 40155941Omlor W, Cecere G, Huang GY, Spiller T, Misra AR, Rabe F, Kallen N, Kirschner M, Surbeck W, Burrer A, Garibaldi G, Holiga S, Dukart J, Umbricht D, Homan P. Exploratory analysis of the relationship between striatal connectivity and apathy during phosphodiesterase 10 inhibition in schizophrenia: findings from a randomized crossover trial. BMC Med. 2025 Mar 28;23(1):187. doi: 10.1186/s12916-025-04004-2.
Derived from this study: PubMed 33192706Umbricht D, Cheng WY, Lipsmeier F, Bamdadian A, Lindemann M. Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms. Front Psychiatry. 2020 Sep 16;11:574375. doi: 10.3389/fpsyt.2020.574375. eCollection 2020.

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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.

Clinical Trials study director

Hoffmann-La Roche

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RO5545965 in people with Schizophrenia, run by Hoffmann-La Roche at 3 sites 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 10 inclusion and 20 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 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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. 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 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?

Apparent volume of distribution (Vz/F) (time frame: Pre-dose on Days 8, 15, 22, 43, 50, 57, 78, 85 and 96; additional 2 hour post-dose on Days 15, 50, and 85). The study lists 5 primary outcomes in all. 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 NCT02824055, which also lists 2 linked publications.

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 7 Jun 2017.