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

NCT02677207 | Completed Phase 2

• 1 other identifier: JNJ-DEP
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• To evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on cognition

  Brief Assessment of Cognition (BACS)

  two weeks - each study visit

Secondary Outcomes (2)

• To evaluate the effects of JNJ-39393406 on depressive symptoms

  two weeks - each study visit

• To evaluate the effects of JNJ-39393406 on residual depressive symptoms

  two weeks - each study visit

Study Arms (2)

JNJ-39393406

EXPERIMENTAL

2 capsules, once daily for the first week and 4 capsules once a day for the rest of the trial.

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.

Drug: Placebo

Interventions

JNJ-39393406 DRUG

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

JNJ-39393406

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tangent Data: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (4)

Clinical Psychiatric Hospital

Codru, MD2011, Moldova

Location

S.C. Stefi-Dent Srl

Botoșani, Romania

Location

Hospital of Psychiatry and Neurology

Brasov, Romania

Location

Spit. Clinic de Urgenta Militar "Dr. Stefan Odobleja"

Craiova, Romania

Location

MeSH Terms

Conditions

Depression

Interventions

JNJ-39393406

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Michael Davidson, M.D.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 9, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 22, 2020

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

RO (3); MO (1)