Depressive Disorder, MajorPhase 1NCT02067299
A Study to Investigate the Effect of JNJ-42847922 on Polysomnography Measures in Patients With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
A Phase 1 study testing JNJ-42847922 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- JNJ-42847922
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2014to Dec 2014
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants with a current/recurrent or past episode of Major Depressive Disorder (MDD) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
- Stably treated with selective serotonin re-uptake inhibitor / serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
- Insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
- Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
- Female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
Who cannot join
- Has a current diagnosis of a psychotic disorder, MDD with psychosis, bipolar disorder, mental retardation, or cluster B personality disorder (eg, borderline personality disorders, antisocial personality disorder)
- Has been diagnosed with sleep-related breathing disorder
- Has suicidal ideation with some intent to act, or has homicidal ideation/intent, per Principal Investigator's clinical judgment
- Abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
- Has uncontrolled hypertension at screening and Day 1 prior to randomization; or any past history of hypertensive crisis
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Single Dose, 4-way Crossover, Placebo-controlled, Randomized Study to Investigate the Effect of JNJ-42847922 on Polysomnography (PSG) Measures in Subjects With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
The purpose of the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).
Read the detailed description
This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (the study medication is assigned by chance) 4-way crossover (method used to switch participants to 4 different arms in a clinical study), and a single dose study. This study will consist of a screening phase (between 28 to 2 days prior to the study medication), a treatment phase of 4 double blind study periods (2 days), and a follow-up phase (within 7 to 14 days after last dose of the study medication). Approximately 20 participants with major depressive disorder will participate in this study. Participants will be randomly assigned to 1 of 4 cohorts (groups) (Cohorts A, B, C, and D) to receive JNJ-42847922 (10 mg, 20 mg, and 40 mg) and placebo. Each cohort consists of 4 treatment periods (Periods 1, 2, 3, and 4). Safety will be evaluated by the assessment vital signs, 12-lead electrocardiogram, clinical laboratory testing, physical examination, and neurological examination. The total duration of study participation for a participant will be approximately 9 to 10 weeks.
- Conditions
- Depressive Disorder, Major
- Being tested
- JNJ-42847922, Placebo
- Keywords
- Depressive Disorder, Major, Major Depressive Disorder, Insomnia, JNJ-42847922, Placebo
- Medical subject headings
- Depressive Disorder, Major, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42847922Drug
Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods.
PlaceboOther
Participants will receive placebo orally on Day 1 of the appropriate treatment periods.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | 5 participants will be included in this cohort. Participants will receive the study medications in the sequence of placebo (Period 1), JNJ-42847922 10 mg (Period 2), JNJ-42847922 20 mg (Period 3), and JNJ-42847922 40 mg (Period 4). Each treatment period and each subsequent treatment period will be separated by 1 week. Receives: Drug: JNJ-42847922; Other: Placebo |
| Cohort B | Experimental | 5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 10 mg (Period 1), JNJ-42847922 40 mg (Period 2), placebo (Period 3), and JNJ-42847922 20 mg (Period 4). Each subsequent treatment period will be separated by 1 week. Receives: Drug: JNJ-42847922; Other: Placebo |
| Cohort C | Experimental | 5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 20 mg (Period 1), placebo (Period 2), JNJ-42847922 40 mg (Period 3), and JNJ-42847922 10 mg (Period 4). Each subsequent treatment period will be separated by 1 week. Receives: Drug: JNJ-42847922; Other: Placebo |
| Cohort D | Experimental | 5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 40 mg (Period 1), JNJ-42847922 20 mg (Period 2), JNJ-42847922 10 mg (Period 3), and placebo (Period 4). Each subsequent treatment period will be separated by 1 week. Receives: Drug: JNJ-42847922; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency to Persistent Sleep (LPS) on Day 1
LPS is with lights off, appearance of first epoch of Stage 1 (light sleep), Stage 2 (light sleep), Stage 3 (deep sleep), and Stage 4 (rapid eye movement sleep) sleep followed by at least 20 consecutive epochs without any Stage 0 sleep (awake but sleepy). LPS will be accessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Day 1
Secondary outcomes (17)
Number of participants with adverse events
Measured: Up to Week 10
Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922
Cmax is defined as maximum observed analyte concentration. This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922
Tmax is defined as actual sampling time to reach maximum observed analyte concentration. This be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12])
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 is area under the plasma concentration-time curve from 0 to 12 hours post dosing. This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Total amount of JNJ-42847922 excreted in urine (Ae12)
Total amount of JNJ-42847922 excreted in urine is expressed as a percentage of dose administered. This will be measured overnight after the administration of the study medication on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose and postdose Day 1
Renal clearance (CLR)
CLR will be measured overnight after the administration of the study medication on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose and postdose Day 1
Number of participants with suicidal ideation or behavior measured using Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Only items with yes responses are listed. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Total sleep time in participants
This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Sleep efficiency in participants
This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 measured using visual analogue scale (VAS) for sleepiness
VAS scale is ued to measure subjective characteristics or attitudes that cannot be measured directly for sleepiness. VAS will assess whether the participants were feeling sleepy during the first hour after wake-up by using a 10 cm line, having sleepy/tired and awake at either end. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 measured using the Bond and Lader visual analogue scale (VAS) to rate subjective feelings
The Bond-Lader Visual Analogue Scale (VAS) is made up of 16 pairs of alternative descriptors of mood and attention at either end of a 10 cm line. Participants were asked to rate their feelings at the time of assessment by indicating the point on the line which best represent their mood. Each item was scored by measuring the position relative to the left hand end of the line and levels of anxiety, sedation, and dysphoria were then calculated from the combined scores of selected items. The scores ranged from 0 to 100, with a high score reflecting a high level of anxiety, sedation or dysphoria. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 on body movements measured using a pot string meter and a stabilometric platform
A pot string meter includes a string attached the waist of the participant and all body movements over a period of time are integrated and expressed as mm sway. In a stabilometric platform, the participant will be made to sleep on a firm surface for about 51.2 seconds each with first eyes open and then eyes closed. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 on saccadic eye movements
Saccadic eye movements will be assessed using a computer-based system connected to electrodes placed lateral of the eyes or using infra-red technology. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Number of participants with depressive symptoms measured using Quick Inventory of Depressive Symptomatology - Self Report 14-item (QIDS-SR14)
The QIDS-SR14, s a version of the QIDS-SR16 with a shorter, 24-hour recall period that has been developed for this trial. The total score ranges from 0 to 27. Using a scale of severity of depression of none, mild, moderate, severe, and very severe, corresponding QIDS-SR16 total scores are none 1-5, mild 6-10, moderate 11-15, severe 16-20 and very severe 21-27. Higher scores indicate worsening. This will be assessed on Days 1 and 2 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2), Day 1, and Day 2
Concentration of cortisol in saliva
This will be measured on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Predose Day 1 (30 minutes and 90 minutes) and postdose Day 2 (at wake-up and 30 minutes after wake-up)
Time spent awake by the participants
This will be assessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2) and Day 1
Total time spent deep sleep by the participants
This will be assessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
Measured: Screening (Day -28 to Day -2) and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, L.L. C. Clinical Trial, Study director, Janssen Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02067299
- Sponsor's protocol ID
- CR103409
- Other IDs
- 42847922EDI1002
- Status last verified
- Feb 2016
- First submitted
- 22 Jan 2014
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose, 4-way Crossover, Placebo-controlled, Randomized Study to Investigate the Effect of JNJ-42847922 on Polysomnography (PSG) Measures in Subjects With Major Depressive Disorder With Insomnia Who Are Stably Treated With Antidepressants
- ClinicalTrials.gov ID
- NCT02067299
- Acronym / sponsor ID
- CR103409
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Major, Major Depressive Disorder, Insomnia, JNJ-42847922, Placebo
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Feb 2014 (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 the study is to evaluate effect of JNJ-42847922 on sleep latency (latency to persistent sleep) in participants with major depressive disorder who are stably treated with selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor who suffer from insomnia (inability to fall asleep).
Detailed description
This is a double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (placebo is compared with the study medication to test whether the study medication has a real effect in clinical study), randomized (the study medication is assigned by chance) 4-way crossover (method used to switch participants to 4 different arms in a clinical study), and a single dose study. This study will consist of a screening phase (between 28 to 2 days prior to the study medication), a treatment phase of 4 double blind study periods (2 days), and a follow-up phase (within 7 to 14 days after last dose of the study medication). Approximately 20 participants with major depressive disorder will participate in this study. Participants will be randomly assigned to 1 of 4 cohorts (groups) (Cohorts A, B, C, and D) to receive JNJ-42847922 (10 mg, 20 mg, and 40 mg) and placebo. Each cohort consists of 4 treatment periods (Periods 1, 2, 3, and 4). Safety will be evaluated by the assessment vital signs, 12-lead electrocardiogram, clinical laboratory testing, physical examination, and neurological examination. The total duration of study participation for a participant will be approximately 9 to 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: JNJ-42847922, Other: Placebo5 participants will be included in this cohort. Participants will receive the study medications in the sequence of placebo (Period 1), JNJ-42847922 10 mg (Period 2), JNJ-42847922 20 mg (Period 3), and JNJ-42847922 40 mg (Period 4). Each treatment period and each subsequent treatment period will be separated by 1 week. |
| Cohort B | Experimental | Drug: JNJ-42847922, Other: Placebo5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 10 mg (Period 1), JNJ-42847922 40 mg (Period 2), placebo (Period 3), and JNJ-42847922 20 mg (Period 4). Each subsequent treatment period will be separated by 1 week. |
| Cohort C | Experimental | Drug: JNJ-42847922, Other: Placebo5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 20 mg (Period 1), placebo (Period 2), JNJ-42847922 40 mg (Period 3), and JNJ-42847922 10 mg (Period 4). Each subsequent treatment period will be separated by 1 week. |
| Cohort D | Experimental | Drug: JNJ-42847922, Other: Placebo5 participants will be included in this cohort. Participants will receive the study medications in the sequence of JNJ-42847922 40 mg (Period 1), JNJ-42847922 20 mg (Period 2), JNJ-42847922 10 mg (Period 3), and placebo (Period 4). Each subsequent treatment period will be separated by 1 week. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants with a current/recurrent or past episode of Major Depressive Disorder (MDD) as established per mini international neuropsychiatric interview at screening or otherwise specified by the treating physician
- Stably treated with selective serotonin re-uptake inhibitor / serotonin-norepinephrine reuptake inhibitor monotherapy, with no change in dose in the last 30 days before screening
- Insomnia per polysomnography (a diagnostic test to measure and record physiologic variables like latency to persistent sleep, total sleep time, sleep efficiency, time spent awake, and total time spent in deep sleep, during sleep)
- Participants must be healthy / medically stable on the basis of clinical laboratory tests performed at screening
- Female participants should not be of child bearing potential due to either tubal ligation or hysterectomy or who are postmenopausal (no spontaneous menses for at least 2 years)
Key exclusion criteria (5 listed)
- Has a current diagnosis of a psychotic disorder, MDD with psychosis, bipolar disorder, mental retardation, or cluster B personality disorder (eg, borderline personality disorders, antisocial personality disorder)
- Has been diagnosed with sleep-related breathing disorder
- Has suicidal ideation with some intent to act, or has homicidal ideation/intent, per Principal Investigator's clinical judgment
- Abnormal day/night rhythm, eg, nightshift worker, or normal bed time past midnight
- Has uncontrolled hypertension at screening and Day 1 prior to randomization; or any past history of hypertensive crisis
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 |
|---|---|---|
| JNJ-42847922Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods. | Drug | Cohort A, Cohort B, Cohort C, Cohort D |
| PlaceboParticipants will receive placebo orally on Day 1 of the appropriate treatment periods. | Other | Cohort A, Cohort B, Cohort C, Cohort D |
Primary outcome
Latency to Persistent Sleep (LPS) on Day 1
Time frame: Day 1
LPS is with lights off, appearance of first epoch of Stage 1 (light sleep), Stage 2 (light sleep), Stage 3 (deep sleep), and Stage 4 (rapid eye movement sleep) sleep followed by at least 20 consecutive epochs without any Stage 0 sleep (awake but sleepy). LPS will be accessed on Day 1 of each treatment period (Periods 1, 2, 3, and 4).
17 secondary outcomes
Number of participants with adverse events
Time frame: Up to Week 10
Maximum Observed Plasma Concentration (Cmax) of JNJ-42847922
Time frame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-42847922
Time frame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Area Under the Plasma Concentration-Time Curve From Time Zero to Time 12 (AUC[12])
Time frame: Predose, and postdose Day 1 (20 minutes, 8 hours 20 minutes, and 12 hours)
Total amount of JNJ-42847922 excreted in urine (Ae12)
Time frame: Predose and postdose Day 1
Renal clearance (CLR)
Time frame: Predose and postdose Day 1
Number of participants with suicidal ideation or behavior measured using Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Total sleep time in participants
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Sleep efficiency in participants
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 measured using visual analogue scale (VAS) for sleepiness
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 measured using the Bond and Lader visual analogue scale (VAS) to rate subjective feelings
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 on body movements measured using a pot string meter and a stabilometric platform
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Next-day residual effect of JNJ-42847922 on saccadic eye movements
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Number of participants with depressive symptoms measured using Quick Inventory of Depressive Symptomatology - Self Report 14-item (QIDS-SR14)
Time frame: Screening (Day -28 to Day -2), Day 1, and Day 2
Concentration of cortisol in saliva
Time frame: Predose Day 1 (30 minutes and 90 minutes) and postdose Day 2 (at wake-up and 30 minutes after wake-up)
Time spent awake by the participants
Time frame: Screening (Day -28 to Day -2) and Day 1
Total time spent deep sleep by the participants
Time frame: Screening (Day -28 to Day -2) and Day 1
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 4 Feb 2016.
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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.
Janssen Research & Development, L.L. C. Clinical Trial study director
Janssen Research & Development, L.L.C.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-42847922 in people with Depressive Disorder, Major, run by Janssen Research & Development, LLC at 2 sites in 2 countries.
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 5 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 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Netherlands. 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?
Latency to Persistent Sleep (LPS) on Day 1 (time frame: Day 1). 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 4 Feb 2016.