SchizophreniaPhase 1NCT02614586
Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia
A Phase 1 study testing TAK-058 and Ondansetron in people with Schizophrenia, run by Takeda at 1 site in United States.
Trial summary
The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- TAK-058 and Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of informed consent.
- Has acceptable clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis).
- Meets schizophrenia criteria as defined by the Diagnostic \& Statistical Manual of Mental Disorders, 5th Edition (DSM-V).
- Are on a stable dose of single second-generation antipsychotics (SGA) for at least 2 months prior to Screening as documented by medical history and assessed by site staff.
- Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than equal to (<=) 85.
- Has a P50 ratio of > 0.5 at both screening assessments.
Who cannot join
- Has a history in the last year or currently receiving treatment with clozapine or olanzapine.
- Has taken any excluded medications, supplements or food products.
- Has a history of gastrointestinal disease that would influence the absorption of study drug or have a significant medical history of any disease that would contraindicate the administration of TAK-058, ondansetron, or a similar compound.
- Has substance abuse or dependence within previous 12 months, unstable mood or anxiety disorder.
- Has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
- Has clinically meaningful hearing loss per investigator's judgment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of TAK-058 and Ondansetron on P50 Auditory Gating in Subjects With Stable Schizophrenia
The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.
Read the detailed description
The drug being tested in this study is called TAK-058. TAK-058 is being tested to evaluate its effects on P50 auditory gating in people who have stable schizophrenia. This study will look at the effect of TAK-058 on P50 auditory gaiting of people with schizophrenia.
This study will be performed in a sequential manner progressing from an optimization (screening) phase in healthy volunteers, to screening of subjects with schizophrenia in part 1, to a 3 period crossover treatment phase in part 2. In the screening phase, 15 healthy volunteers will be enrolled to optimize the settings for the measurement of neurophysiological markers prior to any dosing in participants with schizophrenia. If optimization is not reached, the study will be terminated. In part 1 participants with schizophrenia will receive 2 P50 electroencephalography (EEG) sessions. A measurable deficit in auditory P50 gating S2/S1 ratio greater than (>) 0.5 will be established during this phase. The intraclass correlation coefficient (ICC) will be calculated for the P50 auditory gating S2/S1 ratios collected during the 2 sessions. If these P50 auditory gating S2/S1 ratio measurements are found to have at least a fair level of agreement within individuals (that is, ICC > 0.5), part 2 of the study will begin. 12 participants demonstrating P50 impairment in part 1, will be randomly assigned (by chance, like flipping a coin) to one of the six treatment crossover sequences -which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Placebo + TAK-058 + Ondansetron
- TAK-058 + Placebo + Ondansetron
- Ondansetron + Placebo + TAK-058
- Placebo + Ondansetron + TAK-058
- TAK-058 + Ondansetron + Placebo
- Ondansetron + TAK-058 + Placebo
All participants will be asked to take one dose of capsule, followed 1 hour later by one dose of solution on Day 1 of each intervention period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 118 days. Participants will make be confined to the clinic for 3 days (Day -1 through Day 2 of each period), a final visit for schizophrenic participants in Part 2 after receiving TAK-058, on Day 2 of Period 3 (no final visit for optimization phase healthy participants), and a telephonic follow up assessment 21 days after last dose of study drug.
- Conditions
- Schizophrenia
- Being tested
- TAK-058, Ondansetron, TAK-058 Placebo, Ondansetron Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-058Drug
TAK-058 oral solution.
OndansetronDrug
Ondansetron capsule.
TAK-058 PlaceboDrug
TAK-058 placebo-matching, solution.
Ondansetron PlaceboDrug
Ondansetron placebo-matching, capsule.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + TAK-058 + Ondansetron | Experimental | TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 milligram (mg), solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
| TAK-058 + Placebo + Ondansetron | Experimental | TAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
| Ondansetron + Placebo + TAK-058 | Experimental | Ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
| Placebo + Ondansetron + TAK-058 | Experimental | TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
| TAK-058 + Ondansetron + Placebo | Experimental | TAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
| Ondansetron + TAK-058 + Placebo | Experimental | Ondansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). Receives: Drug: TAK-058; Drug: Ondansetron; Drug: TAK-058 Placebo; Drug: Ondansetron Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058
Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.
Measured: Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.
Secondary outcomes (1)
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Part 2: Day 1 of Intervention Period 1 up to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614586
- Sponsor's protocol ID
- TAK-058-1003
- Other IDs
- U1111-1168-1522
- Status last verified
- Mar 2017
- First submitted
- 23 Nov 2015
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-Controlled Study to Evaluate the Effect of a Single Dose of TAK-058 and Ondansetron on P50 Auditory Gating in Subjects With Stable Schizophrenia
- ClinicalTrials.gov ID
- NCT02614586
- Acronym / sponsor ID
- TAK-058-1003
- Conditions
- Schizophrenia
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 1 May 2017
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 determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.
Detailed description
The drug being tested in this study is called TAK-058. TAK-058 is being tested to evaluate its effects on P50 auditory gating in people who have stable schizophrenia. This study will look at the effect of TAK-058 on P50 auditory gaiting of people with schizophrenia.
This study will be performed in a sequential manner progressing from an optimization (screening) phase in healthy volunteers, to screening of subjects with schizophrenia in part 1, to a 3 period crossover treatment phase in part 2. In the screening phase, 15 healthy volunteers will be enrolled to optimize the settings for the measurement of neurophysiological markers prior to any dosing in participants with schizophrenia. If optimization is not reached, the study will be terminated. In part 1 participants with schizophrenia will receive 2 P50 electroencephalography (EEG) sessions. A measurable deficit in auditory P50 gating S2/S1 ratio greater than (>) 0.5 will be established during this phase. The intraclass correlation coefficient (ICC) will be calculated for the P50 auditory gating S2/S1 ratios collected during the 2 sessions. If these P50 auditory gating S2/S1 ratio measurements are found to have at least a fair level of agreement within individuals (that is, ICC > 0.5), part 2 of the study will begin. 12 participants demonstrating P50 impairment in part 1, will be randomly assigned (by chance, like flipping a coin) to one of the six treatment crossover sequences -which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Placebo + TAK-058 + Ondansetron
- TAK-058 + Placebo + Ondansetron
- Ondansetron + Placebo + TAK-058
- Placebo + Ondansetron + TAK-058
- TAK-058 + Ondansetron + Placebo
- Ondansetron + TAK-058 + Placebo
All participants will be asked to take one dose of capsule, followed 1 hour later by one dose of solution on Day 1 of each intervention period.
This single-center trial will be conducted in the United States. The overall time to participate in this study is approximately 118 days. Participants will make be confined to the clinic for 3 days (Day -1 through Day 2 of each period), a final visit for schizophrenic participants in Part 2 after receiving TAK-058, on Day 2 of Period 3 (no final visit for optimization phase healthy participants), and a telephonic follow up assessment 21 days after last dose of study drug.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo + TAK-058 + Ondansetron | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboTAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 milligram (mg), solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days). |
| TAK-058 + Placebo + Ondansetron | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboTAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of third intervention period (2 days). |
| Ondansetron + Placebo + TAK-058 | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboOndansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). |
| Placebo + Ondansetron + TAK-058 | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboTAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). |
| TAK-058 + Ondansetron + Placebo | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboTAK-058 150 mg, solution, orally along with ondansetron placebo-matching capsule orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by ondansetron 16 mg, capsule, orally, along with TAK-058 placebo-matching solution, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). |
| Ondansetron + TAK-058 + Placebo | Experimental | Drug: TAK-058, Drug: Ondansetron, Drug: TAK-058 Placebo, Drug: Ondansetron PlaceboOndansetron 16 mg, capsule, orally along with TAK-058 placebo-matching solution, orally, on Day 1 of first intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 150 mg, solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of second intervention period (2 days), followed by 1 week washout period, further followed by TAK-058 placebo-matching solution, orally, along with ondansetron placebo-matching capsule, orally, on Day 1 of third intervention period (2 days). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of informed consent.
- Has acceptable clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis).
- Meets schizophrenia criteria as defined by the Diagnostic \& Statistical Manual of Mental Disorders, 5th Edition (DSM-V).
- Are on a stable dose of single second-generation antipsychotics (SGA) for at least 2 months prior to Screening as documented by medical history and assessed by site staff.
- Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than equal to (<=) 85.
Key exclusion criteria (6 listed)
- Has a history in the last year or currently receiving treatment with clozapine or olanzapine.
- Has taken any excluded medications, supplements or food products.
- Has a history of gastrointestinal disease that would influence the absorption of study drug or have a significant medical history of any disease that would contraindicate the administration of TAK-058, ondansetron, or a similar compound.
- Has substance abuse or dependence within previous 12 months, unstable mood or anxiety disorder.
- Has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/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 |
|---|---|---|
| TAK-058TAK-058 oral solution. | Drug | Ondansetron + Placebo + TAK-058, Ondansetron + TAK-058 + Placebo, Placebo + Ondansetron + TAK-058, Placebo + TAK-058 + Ondansetron, TAK-058 + Ondansetron + Placebo, TAK-058 + Placebo + Ondansetron |
| OndansetronOndansetron capsule. | Drug | Ondansetron + Placebo + TAK-058, Ondansetron + TAK-058 + Placebo, Placebo + Ondansetron + TAK-058, Placebo + TAK-058 + Ondansetron, TAK-058 + Ondansetron + Placebo, TAK-058 + Placebo + Ondansetron |
| TAK-058 PlaceboTAK-058 placebo-matching, solution. | Drug | Ondansetron + Placebo + TAK-058, Ondansetron + TAK-058 + Placebo, Placebo + Ondansetron + TAK-058, Placebo + TAK-058 + Ondansetron, TAK-058 + Ondansetron + Placebo, TAK-058 + Placebo + Ondansetron |
| Ondansetron PlaceboOndansetron placebo-matching, capsule. | Drug | Ondansetron + Placebo + TAK-058, Ondansetron + TAK-058 + Placebo, Placebo + Ondansetron + TAK-058, Placebo + TAK-058 + Ondansetron, TAK-058 + Ondansetron + Placebo, TAK-058 + Placebo + Ondansetron |
Primary outcome
Change From Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058
Time frame: Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.
Participants were planned to check for P50 gating ratio. Stimulus signal of 90 decibel pulses of 0.1 millisecond (msec) was to be generated and recorded the event-related potential waveforms. 32 pairs of auditory clicks were to be presented every 10 seconds, with a 500 msec interclick interval. S1 is defined as the conditioning P50 wave with the most positive peak between 30 and 90 msec after the conditioning stimulus. S2 is defined as the test P50 wave with the positive peak after the test stimulus that was closest in latency to the conditioning P50. Amplitude is the difference between the positive peak and the preceding negative trough for both waves. The data from the vertex (Cz site) was to be collected and the P50 gating ratio (S2/S1) was to be calculated as the ratio of the test P50 amplitude to the conditioning P50 amplitude.
1 secondary outcome
Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Part 2: Day 1 of Intervention Period 1 up to Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Medical Director study director
Takeda
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 TAK-058 and Ondansetron in people with Schizophrenia, run by Takeda 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 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 1 May 2017. 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?
Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Baseline in P50 Ratio S2/S1 at Central (Cz) Electrode Following Administration of TAK-058 (time frame: Part 2: Day 1 pre-dose and at multiple time points (up to 2 hours) post-dose in each period.). 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 1 May 2017.