The Effect of Nicotine on Arousal, Cognition and Social Cognition in Schizophrenic Patients

NCT01186471 | Completed Early Phase 1

• 1 other identifier: CR017263
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study in patients with stable schizophrenia will investigate the effect of nicotine on arousal, cognitive task and social cognition after acute dose administration.

Conditions

Schizophrenia; Cognition Disorders

Keywords

Symptomatic treatment; Cognition; Cognitive deficits; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Event related potentials (P50, P300, N100) and measures of standard cognition and social cognition

  1 hour post dose

Secondary Outcomes (1)

• Nicotine exposure

  predose and 5 min post each dosing

Study Arms (3)

001

EXPERIMENTAL

A643 (nicotine) 1mg oromucosal nicotine spray- three times daily during each treatment period

Other: A643 (nicotine)

002

EXPERIMENTAL

A643 (nicotine) 2mg oromucosal nicotine spray- three times daily during each treatment period

Other: A643 (nicotine)

003

PLACEBO COMPARATOR

placebo placebo - three times daily during each treatment period

Drug: placebo

Interventions

A643 (nicotine) OTHER

1mg oromucosal nicotine spray- three times daily during each treatment period

001

placebo DRUG

placebo - three times daily during each treatment period

003

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In- or outpatients with schizophrenia stably treated (same primary medication) for at least 2 months with antipsychotic therapy (treatment with more than 1 antipsychotic drug is acceptable provided dose levels have been stable for \> 2 months). Fluctuations in dose levels of the primary antipsychotic treatment are acceptable provided the dose levels remain constant as from 2 weeks prior to dosing
• A known (by the site) disease history of at least 12 months
• DSM-IV criteria for Schizophrenia
• Willing to be hospitalized during the treatment periods of the study
• Body mass index (BMI) between 18 and 35 kg/m2, inclusive (BMI = weight/height2)
• Women must be: postmenopausal (for at least 12 months), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (at the discretion of the investigator/per local regulations), or if sexually active, be practicing a highly effective method of birth control and must agree to continue to use the same method of contraception throughout the study
• Women of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission (each study period)
• Smoking on average a minimum of 15 cigarettes (or equivalent) per day within 6 months prior to study drug administration (only for Cohort 1)

You may not qualify if:

• Female patients who are pregnant or breastfeeding
• Clinically significant abnormal values for clinical chemistry, hematology or urinalysis at screening. It is expected that laboratory values will generally be within the normal range for the laboratory, though minor deviations, which are not considered to be of clinical significance to the investigator, are acceptable. Values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2 fold ULN will be allowed
• Clinically significant abnormal physical examination, vital signs or 12-lead ECG at screening
• A DSM-IV axis I diagnosis other than schizophrenia that has been the focus of treatment or cause of disability in the last 6 months (such as Major Depressive Episode)
• Evidence of substance dependence other than nicotine (DSM-IV) in the last 6 months
• History of or current significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, unmanaged high BP, hematological disease, bronchospastic respiratory disease, renal or hepatic insufficiency, Parkinson's disease, infection (HIV, Hepatitis C), or any other illness that the Investigator considers should exclude the subject (Subjects with mild hypertension, lipid abnormalities, diabetes mellitus or thyroid disease are allowed if no significant treatment changes were required in the past 6 months)
• Use of anti-parkinsonian agents in the past 2 months
• Suicidal risk (assessed by the investigator), prior attempts to suicide, command hallucinations and / or hopelessness
• Smoking cigarettes (or equivalents) or the use of nicotine based products within 3 months prior to study drug administration (only for Cohort 2)
• Current use of any medication for smoking cessation such as nicotine replacement therapy, bupropion or varenicline
• History of epilepsy or fits or unexplained black-outs

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator

MeSH Terms

Conditions

Schizophrenia; Cognition Disorders

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Janssen Pharmaceutica N.V. Clinical Trial

  Janssen Pharmaceutica N.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 23, 2010
• Study Start: May 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03