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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: JNJ-39393406; Drug: Placebo

Detailed Description

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• Moldova, Republic of
  • Codru, Moldova, Republic of, MD2011
    • Clinical Psychiatric Hospital
• Romania
  • Botosani, Romania
    • S.C. Stefi-Dent Srl
  • Brasov, Romania
    • Hospital of Psychiatry and Neurology
  • Craiova, Romania
    • Spit. Clinic de Urgenta Militar "Dr. Stefan Odobleja"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Meet DSM V criteria for history of MDD or BPD by MINI.
2. Between 18-50 years of age, male or female subjects of any race, smokers and non-smokers.
3. 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.
4. Have a MADRS ≥ 10 and ≤ 34 and an YMRS < 7.
5. 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.
6. 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).
7. 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.
8. 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.)

Exclusion Criteria:

1. Women of child bearing potential who do not practice contraception.
2. Psychosis, florid manic or major depressive episode during the 4 weeks preceding baseline day or current psychosis.
3. Patients on more than 2 psychotropic (hypnotics for sleep and occasional SOS for agitation do not count).
4. Smokes more than 40 cigarettes per day.
5. 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).
6. Has a clinically significant abnormal 12-lead electrocardiogram (ECG) at Screening Visit 1 as determined by the Investigator.
7. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
8. Patients with a current DSM-V substance or alcohol dependence.
9. Concurrent delirium, mental retardation, drug-induced psychosis, or history of stroke, brain degenerative disorders and brain trauma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-39393406; 2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.	Drug: JNJ-39393406; JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
Placebo Comparator: Placebo; 2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.	Drug: Placebo; JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tangent Data
• Collaborators: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Investigators: Principal Investigator: Michael Davidson, M.D., Principal Investigator

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: JNJ-DEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES