DepressionPhase 2JNJ-DEPNCT02677207

The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive

A Phase 2 study testing JNJ-39393406 in people with Depression, run by Tangent Data at 4 sites in 2 countries.

Completed

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

Trial summary

To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric performance and residual depressive symptoms in patients who have been diagnosed with unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major Depression or Manic Episode. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Depression
What is being tested?: JNJ-39393406
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 4 sitesin 2 countries
Study dates: Feb 2016to Jul 2017
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Meet DSM V criteria for history of MDD or BPD by MINI.
Between 18-50 years of age, male or female subjects of any race, smokers and non-smokers.
Able to provide informed consent. All participant patients must have signed an informed consent document indicating they understand the purpose of the study and the procedures required for the study and are willing to participate by complying with the study procedures and restrictions.
Have a MADRS ≥ 10 and ≤ 34 and an YMRS < 7.
In the opinion of the investigator, basic education and severity of symptoms (psychotic, negative, manic, agitation, depression) do not prevent the patient from attending to the cognitive tasks.
In the opinion of the investigator the patient can be safely treated with no more than 2 psychotropic medications as background therapy (SOS for agitation and sleeping medication are allowed in addition to the 2 psychotropics).
The background psychotropic(s) that will be continued through-out the 2 week trial must have been started at least 2 weeks prior to the baseline day at doses allowed by the local regulations and no changes in dose have been made during this pre-baseline 2 week period.
Inpatients or out-patients at the discretion of the investigator (If outpatients the Readiness for Discharge Scale has to be administered at baseline and at each visit.)

Who cannot join

Women of child bearing potential who do not practice contraception.
Psychosis, florid manic or major depressive episode during the 4 weeks preceding baseline day or current psychosis.
Patients on more than 2 psychotropic (hypnotics for sleep and occasional SOS for agitation do not count).
Smokes more than 40 cigarettes per day.
Unstable medical disease (malignancy, poorly controlled diabetes, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Particular attention should be given to exclude patients with ischemic heart disease).
Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.

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At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
Patients with a current DSM-V substance or alcohol dependence.
Concurrent delirium, mental retardation, drug-induced psychosis, or history of stroke, brain degenerative disorders and brain trauma.

Trial locations and contacts

4 sites in 2 countries.

Country

City, postcode or hospital

4 sites in 2 countries

Romania3 sites

S.C. Stefi-Dent Srl
Botoșani
Hospital of Psychiatry and Neurology
Brasov
Spit. Clinic de Urgenta Militar "Dr. Stefan Odobleja"
Craiova

Other trials in Romania

Moldova1 site

Clinical Psychiatric Hospital
Codru, MD2011

Other trials in Moldova

About this study

Official title: The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive Symptoms in 80 Patients With Unipolar or Bipolar Depression: a Phase II Exploratory add-on Double Blind Placebo Controlled 2 Week Trial

Read the detailed description

Hypothesis: Allosteric modulation of the a7nAChR with JNJ-39393406 improves psychometric performance and residual depressive symptoms in patients with unipolar major depression disorder (MDD) or bipolar depression (BPD).

Outcome measurements:

BACS
MADRS
BNSS
CGI-S- BP,
Questionnaire on smoking urges (QSU) and time to the first cigarette after waking up in the morning,
Readiness for discharge scale.

Conditions: Depression
Being tested: JNJ-39393406, Placebo
Medical subject headings: Depression

What participants receive

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

JNJ-39393406Drug
JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
PlaceboDrug
JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial

Study groups in NCT02677207
Study group	Role	What they receive
JNJ-39393406	Experimental	2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial. Receives: Drug: JNJ-39393406
Placebo	Placebo comparator	2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial. Receives: Drug: Placebo

What is being measured

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

To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition
Brief Assessment of Cognition (BACS)
Measured: two weeks - each study visit

Secondary outcomes (2)

To evaluate the effects of JNJ-39393406 on depressive symptoms
Montgomery-Asberg Depression Scale (MADRS)
Measured: two weeks - each study visit
To evaluate the effects of JNJ-39393406 on residual depressive symptoms
Brief Negative Symptoms Scale (BNSS)
Measured: two weeks - each study visit

Timeline

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

Feb 2016Jul 2017

First posted9 Feb 2016 (estimated)
Study startFeb 2016
Primary completionMay 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02677207
Sponsor's protocol ID: JNJ-DEP
Acronym: JNJ-DEP
Status last verified: Jan 2018
First submitted: 21 Jan 2016
Last updated: 22 May 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes

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 Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive Symptoms in 80 Patients With Unipolar or Bipolar Depression: a Phase II Exploratory add-on Double Blind Placebo Controlled 2 Week Trial
ClinicalTrials.gov ID: NCT02677207
Acronym / sponsor ID: JNJ-DEP / JNJ-DEP
Conditions: Depression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Tangent DataUniversity, hospital or other
Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study start: Feb 2016
Primary completion: May 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 9 Feb 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.

Detailed description

Outcome measurements:

BACS
MADRS
BNSS
CGI-S- BP,
Questionnaire on smoking urges (QSU) and time to the first cigarette after waking up in the morning,
Readiness for discharge scale.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
JNJ-39393406	Experimental	Drug: JNJ-393934062 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.
Placebo	Placebo comparator	Drug: Placebo2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.

Who may qualify

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

Key inclusion criteria (8 listed)

Meet DSM V criteria for history of MDD or BPD by MINI.
Between 18-50 years of age, male or female subjects of any race, smokers and non-smokers.
Able to provide informed consent. All participant patients must have signed an informed consent document indicating they understand the purpose of the study and the procedures required for the study and are willing to participate by complying with the study procedures and restrictions.
Have a MADRS ≥ 10 and ≤ 34 and an YMRS < 7.
In the opinion of the investigator, basic education and severity of symptoms (psychotic, negative, manic, agitation, depression) do not prevent the patient from attending to the cognitive tasks.

Key exclusion criteria (9 listed)

Women of child bearing potential who do not practice contraception.
Psychosis, florid manic or major depressive episode during the 4 weeks preceding baseline day or current psychosis.
Patients on more than 2 psychotropic (hypnotics for sleep and occasional SOS for agitation do not count).
Smokes more than 40 cigarettes per day.
Unstable medical disease (malignancy, poorly controlled diabetes, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning. Particular attention should be given to exclude patients with ischemic heart disease).

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-39393406JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial	Drug	JNJ-39393406
PlaceboJNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial	Drug	Placebo

Primary outcome

To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition
Time frame: two weeks - each study visit
Brief Assessment of Cognition (BACS)

2 secondary outcomes

To evaluate the effects of JNJ-39393406 on depressive symptoms
Time frame: two weeks - each study visit
To evaluate the effects of JNJ-39393406 on residual depressive symptoms
Time frame: two weeks - each study visit

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 22 May 2020.
Individual participant dataSharing planned: Yes

Related trials for Depression

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Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
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Recruiting
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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.

Michael Davidson, M.D. principal investigator

Principal Investigator

4 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-39393406 in people with Depression, run by Tangent Data at 4 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 8 inclusion and 9 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 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Romania, Moldova. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study 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?

To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition (time frame: two weeks - each study visit). 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 NCT02677207.

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 22 May 2020.