Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
NCT ID: NCT01488929
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
603 participants
INTERVENTIONAL
2011-12-31
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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5 mg TC-5619
One tablet of 5 mg TC-5619 will be administered orally once a day.
TC-5619
50 mg TC-5619
One tablet of 50 mg TC-5619 will be administered orally once a day.
TC-5619
Placebo
One tablet of placebo will be administered orally once a day.
Placebo
Interventions
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TC-5619
Placebo
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Stable schizophrenia as documented by lack of psychiatric hospitalization for 2 months prior to Screening (social admissions for the convenience of the subject allowed)
4. Clinical history of stable psychotic symptoms for 1 month prior to Screening.
5. 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.
6. Sum \> 20 for the 7 items in the Negative Symptoms subscale of the PANSS.
7. Calgary Depression Schizophrenia Scale (CDSS) score \< 6.
8. Simpson Angus Scale score \< 12.
9. Outpatient with stable housing, and significant presence of an informant who is not a group home resident.
Exclusion Criteria
2. Significant risk of suicide or attempted suicide in the 12 months before screening, or of danger to themselves or others.
3. Change in dosing of atypical antipsychotic within 2 months of Screening.
4. Treatment with electroconvulsive therapy (ECT) within 12 months of Screening.
5. Treatment with mood stabilizers, antidepressants, anxiolytics (short-acting hypnotics permitted), anticholinergics, or more than 1 antipsychotic within 1 month prior to Screening.
6. Treatment within 1 month prior to Screening with cognition-affecting agents other than the above (e.g. CNS stimulants).
7. History within past 6 months of screening of alcohol or illicit drug abuse.
8. Use of smoking cessation therapy within 1 month prior to Screening.
9. 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).
10. History of significant other major or unstable neurological, neurosurgical (e.g. head trauma), metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder.
11. History of myocardial infarction based on medical history or electrocardiogram (ECG) findings at screening.
12. History of seizure disorder.
13. Type 1 diabetes mellitus.
14. Type 2 diabetes mellitus that requires medication (diet-controlled allowed, with HbA1C \< 7.3).
15. Body Mass Index (BMI) \> 35.
16. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency.
17. Current TB or known systemic infection (e.g., HBV, HCV, HIV).
18. Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF \> 450 for males and \>470 for females.
19. Men, or women of child-bearing potential, who are unwilling or unable to use accepted methods of birth control as specified in Section 4.4.4
20. Women with a positive pregnancy test, or who are lactating.
21. Participated in another clinical trial within 3 months prior to Screening.
18 Years
65 Years
ALL
No
Sponsors
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Targacept Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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David P Walling, PhD
Role: PRINCIPAL_INVESTIGATOR
Collaborative Neuroscience Network, Inc
Locations
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Collaborative Neuroscience Network, Inc
Garden Grove, California, United States
Behavorial Research Specialists
Glendale, California, United States
Apostle Clinical Trials, Inc
Long Beach, California, United States
Synergy Clinical Research Center
National City, California, United States
Excell Research, Inc.
Oceanside, California, United States
Neuropsychiatric Research Center of Orange County
Orange, California, United States
CNRI
San Diego, California, United States
Segal Institute for Clinical Research
Lauderhill, Florida, United States
Compass Research, LLC
Leesburg, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, United States
Precise Research Group
Flowood, Mississippi, United States
St. Charles Psychiatric Associates - Midwest Reserch Group
Saint Charles, Missouri, United States
PsychCare Consultants Research
St Louis, Missouri, United States
CRI Worldwide, LLC
Marlton, New Jersey, United States
Behavioral Medical Research
Brooklyn, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Neuro-Behavorial Clinic Research, Inc.
Canton, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States
Houston Clinical Trials, LLC
Houston, Texas, United States
Semmelweis University, Department of Psychiatry
Budapest, , Hungary
University of Debrecen, Medical and Health Science Centre, Department of Psychiatry
Debrecen, , Hungary
Pharma4Trial Kft.
Gyöngyös, , Hungary
University of Pecs, Department of Psychiatry
Pécs, , Hungary
St. George Hospital, Department of Psychiatry
Székesfehérvár, , Hungary
County Emergency Clinical Hospital of Arad
Arad, Arad, Romania
CMDTA Neomed
Brasov, Brașov County, Romania
Neuropsychiatry Clinical Hospital Craiova, Psychiatry Department
Craiova, Dolj, Romania
SC Lorentina 2102 SRL
Târgovişte, Dâmbovița County, Romania
University Emergency Central Military Hospital, Dept. of Psychiatry
Bucharest, , Romania
Kemerovo Regional Clinical Psychiatric Hospital
Kemerovo, , Russia
Moscow Research Institute of Psychiatry
Moscow, , Russia
Menthal Health Research Center of the RAMS
Moscow, , Russia
Nizhniy Novgorod Regional Psychoneurological Hospital # 1
Nizhny Novgorod, , Russia
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #7)
Saint Petersburg, , Russia
Saint-Petersburg State Public Healthcare Institution (Saint Nicholas Psychiatric Hospital)
Saint Petersburg, , Russia
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #4)
Saint Petersburg, , Russia
Saint-Petersburg Research Psychoneurogical Institute
Saint Petersburg, , Russia
Saint-Petersburg State Healthcare Institution (City Psychiatric Hospital #6)
Saint Petersburg, , Russia
Municiple Healthcare Institution (City Clinical Hospital #2)
Saratov, , Russia
Institution of Russian Academy of Medical Sciences
Tomsk, , Russia
Nizhny Novgorod Region State Budgetary Institution of Healthcare "Clinical Psychiatric Hospital #1 of Nizhny Novgorod"
Veliky Novgorod, , Russia
Yaroslavl State Medical Academy, Department of Psychiatry
Yaroslavl, , Russia
Regional State Healthcare Institution (Sverdlovsk Regional Clinical Psychiatric Hospital)
Yekaterinburg, , Russia
Clinical Centre "Dr Dragisa Misovic", Clinic of Psychiatry
Belgrade, , Serbia
Clinical Centre of Serbia, Clinic of Psychiatry
Belgrade, , Serbia
Institute of Mental Health
Belgrade, , Serbia
Clinical Centre Nis, Psychiatric Clinic
Gornja Toponica, , Serbia
Clinical Centre Kragujevac, Psychiatric Clinic
Kragujevac, , Serbia
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
Vojvodina, , Serbia
Crimean State Medical University (Dept. of Psychiatry)
Simferopol, Autonomous Republic of Crimea, Ukraine
Odesa Regional Psychiatric Hospital #2
Odesa, Kominternivskyy District, Ukraine
Dnipropetrovsk Regional Clinical Hospital
Dnipropetrovsk, , Ukraine
Dnipropetrovsk State Medical Academy, Dept. of Psychiatry
Dnipropetrovsk, , Ukraine
Donetsk National Medical University (Regional Clinical Psychiatric Hospital)
Donetsk, , Ukraine
Institute of Neurology, Psychiatry and Narcology AMS of Ukraine
Kharkiv, , Ukraine
Kharkiv Regional Clinical Psychiatric Hospital N 3
Kharkiv, , Ukraine
Kyiv Station Railway Clinical Hospital # 1 of the STBA "South-Western Railway"
Kyiv, , Ukraine
Lugansk State Medical University
Luhansk, , Ukraine
Odesa Regional Psychoneurological Dispensary
Odesa, , Ukraine
Ukrainian Medical Stomatological Academy, Dept. of Psychiatry
Poltava, , Ukraine
Vinnytsya National Medical University, Dept. of Psychiatry & Narcology
Vinnytsia, , Ukraine
Countries
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Other Identifiers
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TC-5619-23-CRD-003
Identifier Type: -
Identifier Source: org_study_id
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