Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia

NCT01488929 | Completed Phase 2

• 1 other identifier: TC-5619-23-CRD-003
• Study Type: interventional
• Target: 603
• Locations: 6 countries
• Sites: 64

Brief Summary

Negative symptoms and cognitive dysfunction in schizophrenia (CDS) are core features of schizophrenia. These negative symptoms and cognitive deficits have a devastating impact on the function, employment, and social interactions of patients with schizophrenia. Medications used to treat schizophrenia (e.g. atypical antipsychotics) do not improve negative symptoms or CDS. TC-5619 is being developed for use as an add-on therapy in combination with atypical antipsychotics to treat patients with negative symptoms and CDS.

Conditions

Schizophrenia; Negative Symptoms; Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Scale for Assessment of Negative Symptoms (SANS)

  24 weeks

Secondary Outcomes (2)

• Change from baseline in the Cogstate Schizophrenia Battery (CSB)

  24 weeks

• Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief)

  24 weeks

Study Arms (3)

5 mg TC-5619

EXPERIMENTAL

One tablet of 5 mg TC-5619 will be administered orally once a day.

Drug: TC-5619

50 mg TC-5619

EXPERIMENTAL

One tablet of 50 mg TC-5619 will be administered orally once a day.

Drug: TC-5619

Placebo

PLACEBO COMPARATOR

One tablet of placebo will be administered orally once a day.

Drug: Placebo

Interventions

TC-5619 DRUG

5 mg TC-5619; 50 mg TC-5619

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of schizophrenia, per DSM-IV-TR criteria, as aided by the MINI International Neuropsychiatric Interview
• Controlled schizophrenia, on stable dose of an approved atypical antipsychotic for at least 2 months prior to screening. Approved refers to regulatory approval in the country of use.
• Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening (social admissions for the convenience of the subject allowed)
• Clinical history of stable psychotic symptoms for 1 month prior to Screening.
• Stable positive symptoms of schizophrenia for 4 weeks prior to Day 1, as shown by score ≤ 4 on PANSS for items related to delusion, hallucination, conceptual disorganization, and unusual thought content, at Screening and at Day 1.
• Sum \> 20 for the 7 items in the Negative Symptoms subscale of the PANSS.
• Calgary Depression Schizophrenia Scale (CDSS) score \< 6.
• Simpson Angus Scale score \< 12.
• Outpatient with stable housing, and significant presence of an informant who is not a group home resident.

You may not qualify if:

• Diagnosis of schizoaffective or schizophreniform disorders within 1 year prior to Screening.
• Significant risk of suicide or attempted suicide in the 12 months before screening, or of danger to themselves or others.
• Change in dosing of atypical antipsychotic within 2 months of Screening.
• Treatment with electroconvulsive therapy (ECT) within 12 months of Screening.
• Treatment with mood stabilizers, antidepressants, anxiolytics (short-acting hypnotics permitted), anticholinergics, or more than 1 antipsychotic within 1 month prior to Screening.
• Treatment within 1 month prior to Screening with cognition-affecting agents other than the above (e.g. CNS stimulants).
• History within past 6 months of screening of alcohol or illicit drug abuse.
• Use of smoking cessation therapy within 1 month prior to Screening.
• Positive urine drug screen except when related to prescribed short-acting benzodiazepines and opiates recently prescribed for an episode of acute pain (e.g., dental extraction).
• History of significant other major or unstable neurological, neurosurgical (e.g. head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
• History of myocardial infarction based on medical history or electrocardiogram (ECG) findings at screening.
• History of seizure disorder.
• Type 1 diabetes mellitus.
• Type 2 diabetes mellitus that requires medication (diet-controlled allowed, with HbA1C \< 7.3).
• Body Mass Index (BMI) \> 35.

Sponsors & Collaborators

• Targacept Inc.: lead

Study Sites (64)

Collaborative Neuroscience Network, Inc

Garden Grove, California, 92845, United States

Location

Behavorial Research Specialists

Glendale, California, 91206, United States

Location

Apostle Clinical Trials, Inc

Long Beach, California, 90813, United States

Location

Synergy Clinical Research Center

National City, California, 91950, United States

Location

Excell Research, Inc.

Oceanside, California, 92056, United States

Location

Neuropsychiatric Research Center of Orange County

Orange, California, 92868, United States

Location

CNRI

San Diego, California, 92102, United States

Location

Segal Institute for Clinical Research

Lauderhill, Florida, 33319, United States

Location

Compass Research, LLC

Leesburg, Florida, 34749, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30308, United States

Location

Alexian Brothers Behavioral Health Hospital

Hoffman Estates, Illinois, 60169, United States

Location

Precise Research Group

Flowood, Mississippi, 39232, United States

Location

St. Charles Psychiatric Associates - Midwest Reserch Group

Saint Charles, Missouri, 63304, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

CRI Worldwide, LLC

Marlton, New Jersey, 08053, United States

Location

Behavioral Medical Research

Brooklyn, New York, 11241, United States

Location

Finger Lakes Clinical Research

Rochester, New York, 14618, United States

Location

Neuro-Behavorial Clinic Research, Inc.

Canton, Ohio, 44718, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

InSite Clinical Research

DeSoto, Texas, 75115, United States

Location

Houston Clinical Trials, LLC

Houston, Texas, 77098, United States

Location

Semmelweis University, Department of Psychiatry

Budapest, 1083, Hungary

Location

University of Debrecen, Medical and Health Science Centre, Department of Psychiatry

Debrecen, 4032, Hungary

Location

Pharma4Trial Kft.

Gyöngyös, 3200, Hungary

Location

University of Pecs, Department of Psychiatry

Pécs, 7600, Hungary

Location

St. George Hospital, Department of Psychiatry

Székesfehérvár, 8000, Hungary

Location

County Emergency Clinical Hospital of Arad

Arad, Arad, 310022, Romania

Location

CMDTA Neomed

Brasov, Brașov County, 500283, Romania

Location

Neuropsychiatry Clinical Hospital Craiova, Psychiatry Department

Craiova, Dolj, 200473, Romania

Location

SC Lorentina 2102 SRL

Târgovişte, Dâmbovița County, 130081, Romania

Location

University Emergency Central Military Hospital, Dept. of Psychiatry

Bucharest, 010816, Romania

Location

Kemerovo Regional Clinical Psychiatric Hospital

Kemerovo, 650036, Russia

Location

Moscow Research Institute of Psychiatry

Moscow, 107076, Russia

Location

Menthal Health Research Center of the RAMS

Moscow, 115522, Russia

Location

Nizhniy Novgorod Regional Psychoneurological Hospital # 1

Nizhny Novgorod, 603152, Russia

Location

Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #7)

Saint Petersburg, 190005, Russia

Location

Saint-Petersburg State Public Healthcare Institution (Saint Nicholas Psychiatric Hospital)

Saint Petersburg, 190121, Russia

Location

Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #4)

Saint Petersburg, 191119, Russia

Location

Saint-Petersburg Research Psychoneurogical Institute

Saint Petersburg, 192019, Russia

Location

Saint-Petersburg State Healthcare Institution (City Psychiatric Hospital #6)

Saint Petersburg, 193167, Russia

Location

Municiple Healthcare Institution (City Clinical Hospital #2)

Saratov, 410028, Russia

Location

Institution of Russian Academy of Medical Sciences

Tomsk, 634014, Russia

Location

Nizhny Novgorod Region State Budgetary Institution of Healthcare "Clinical Psychiatric Hospital #1 of Nizhny Novgorod"

Veliky Novgorod, 603155, Russia

Location

Yaroslavl State Medical Academy, Department of Psychiatry

Yaroslavl, 150003, Russia

Location

Regional State Healthcare Institution (Sverdlovsk Regional Clinical Psychiatric Hospital)

Yekaterinburg, 620030, Russia

Location

Clinical Centre "Dr Dragisa Misovic", Clinic of Psychiatry

Belgrade, 11000, Serbia

Location

Clinical Centre of Serbia, Clinic of Psychiatry

Belgrade, 11000, Serbia

Location

Institute of Mental Health

Belgrade, 11000, Serbia

Location

Clinical Centre Nis, Psychiatric Clinic

Gornja Toponica, 18202, Serbia

Location

Clinical Centre Kragujevac, Psychiatric Clinic

Kragujevac, 34000, Serbia

Location

Special Hospital for Psychiatric Diseases "Sveti Vracevi"

Vojvodina, 23330, Serbia

Location

Crimean State Medical University (Dept. of Psychiatry)

Simferopol, Autonomous Republic of Crimea, 95006, Ukraine

Location

Odesa Regional Psychiatric Hospital #2

Odesa, Kominternivskyy District, 67513, Ukraine

Location

Dnipropetrovsk Regional Clinical Hospital

Dnipropetrovsk, 49005, Ukraine

Location

Dnipropetrovsk State Medical Academy, Dept. of Psychiatry

Dnipropetrovsk, 49115, Ukraine

Location

Donetsk National Medical University (Regional Clinical Psychiatric Hospital)

Donetsk, 83008, Ukraine

Location

Institute of Neurology, Psychiatry and Narcology AMS of Ukraine

Kharkiv, 61068, Ukraine

Location

Kharkiv Regional Clinical Psychiatric Hospital N 3

Kharkiv, 61068, Ukraine

Location

Kyiv Station Railway Clinical Hospital # 1 of the STBA "South-Western Railway"

Kyiv, 01030, Ukraine

Location

Lugansk State Medical University

Luhansk, 91045, Ukraine

Location

Odesa Regional Psychoneurological Dispensary

Odesa, 65014, Ukraine

Location

Ukrainian Medical Stomatological Academy, Dept. of Psychiatry

Poltava, 36013, Ukraine

Location

Vinnytsya National Medical University, Dept. of Psychiatry & Narcology

Vinnytsia, 21018, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Interventions

N-(2-(pyridin-3-ylmethyl)-1-azabicyclo(2.2.2)oct-3-yl)-1-benzofuran-2-carboxamide

Condition Hierarchy (Ancestors)

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

Study Officials

• David P Walling, PhD

  Collaborative Neuroscience Network, Inc

  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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: December 8, 2011
• Study Start: December 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 3, 2015

Record last verified: 2013-12

Locations

SE (6); UA (12); US (22); RO (5); RU (14); HU (5)