Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
- Conditions
- Cognitive DysfunctionSchizophreniaNegative Symptoms
- Interventions
- Drug: Placebo
- Registration Number
- NCT01488929
- Lead Sponsor
- Targacept Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 603
- 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.
- 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.
- Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency.
- Current TB or known systemic infection (e.g., HBV, HCV, HIV).
- Clinically significant lab or ECG abnormality that could be a safety issue in the study, including QTcF > 450 for males and >470 for females.
- 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
- Women with a positive pregnancy test, or who are lactating.
- Participated in another clinical trial within 3 months prior to Screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 50 mg TC-5619 TC-5619 One tablet of 50 mg TC-5619 will be administered orally once a day. 5 mg TC-5619 TC-5619 One tablet of 5 mg TC-5619 will be administered orally once a day. Placebo Placebo One tablet of placebo will be administered orally once a day.
- Primary Outcome Measures
Name Time Method Change from baseline in the Scale for Assessment of Negative Symptoms (SANS) 24 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (64)
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
Behavorial Research Specialists
🇺🇸Glendale, California, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Compass Research, LLC
🇺🇸Leesburg, Florida, United States
Saint-Petersburg State Public Healthcare Institution (Saint Nicholas Psychiatric Hospital)
🇷🇺St. Petersburg, Russian Federation
Institute of Neurology, Psychiatry and Narcology AMS of Ukraine
🇺🇦Kharkiv, Ukraine
Lugansk State Medical University
🇺🇦Lugansk, Ukraine
Kharkiv Regional Clinical Psychiatric Hospital N 3
🇺🇦Kharkiv, Ukraine
Donetsk National Medical University (Regional Clinical Psychiatric Hospital)
🇺🇦Donetsk, Ukraine
Odesa Regional Psychoneurological Dispensary
🇺🇦Odesa, Ukraine
Nizhniy Novgorod Regional Psychoneurological Hospital # 1
🇷🇺Nizhniy Novgorod, Russian Federation
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #7)
🇷🇺St. Petersburg, Russian Federation
Regional State Healthcare Institution (Sverdlovsk Regional Clinical Psychiatric Hospital)
🇷🇺Yekaterinburg, Russian Federation
Clinical Centre "Dr Dragisa Misovic", Clinic of Psychiatry
🇷🇸Belgrade, Serbia
Clinical Centre Nis, Psychiatric Clinic
🇷🇸Gornja Toponica, Serbia
Ukrainian Medical Stomatological Academy, Dept. of Psychiatry
🇺🇦Poltava, Ukraine
Moscow Research Institute of Psychiatry
🇷🇺Moscow, Russian Federation
St. George Hospital, Department of Psychiatry
🇭🇺Szekesfehervar, Hungary
Yaroslavl State Medical Academy, Department of Psychiatry
🇷🇺Yaroslavl, Russian Federation
Precise Research Group
🇺🇸Flowood, Mississippi, United States
Menthal Health Research Center of the RAMS
🇷🇺Moscow, Russian Federation
Clinical Centre of Serbia, Clinic of Psychiatry
🇷🇸Belgrade, Serbia
Crimean State Medical University (Dept. of Psychiatry)
🇺🇦Simferopol, Autonomous Republic of Crimea, Ukraine
University Emergency Central Military Hospital, Dept. of Psychiatry
🇷🇴Bucharest, Romania
Nizhny Novgorod Region State Budgetary Institution of Healthcare "Clinical Psychiatric Hospital #1 of Nizhny Novgorod"
🇷🇺Novgorod, Russian Federation
Dnipropetrovsk Regional Clinical Hospital
🇺🇦Dnipropetrovsk, Ukraine
Dnipropetrovsk State Medical Academy, Dept. of Psychiatry
🇺🇦Dnipropetrovsk, Ukraine
Kyiv Station Railway Clinical Hospital # 1 of the STBA "South-Western Railway"
🇺🇦Kyiv, Ukraine
Vinnytsya National Medical University, Dept. of Psychiatry & Narcology
🇺🇦Vinnytsya, Ukraine
Neuropsychiatry Clinical Hospital Craiova, Psychiatry Department
🇷🇴Craiova, Dolj County, Romania
Behavioral Medical Research
🇺🇸Brooklyn, New York, United States
Collaborative Neuroscience Network, Inc
🇺🇸Garden Grove, California, United States
St. Charles Psychiatric Associates - Midwest Reserch Group
🇺🇸Saint Charles, Missouri, United States
CRI Worldwide, LLC
🇺🇸Marlton, New Jersey, United States
Apostle Clinical Trials, Inc
🇺🇸Long Beach, California, United States
PsychCare Consultants Research
🇺🇸St. Louis, Missouri, United States
Neuropsychiatric Research Center of Orange County
🇺🇸Orange, California, United States
Segal Institute for Clinical Research
🇺🇸Lauderhill, Florida, United States
Pharma4Trial Kft.
🇭🇺Gyongyos, Hungary
CMDTA Neomed
🇷🇴Brasov, Brasov County, Romania
Kemerovo Regional Clinical Psychiatric Hospital
🇷🇺Kemerovo, Russian Federation
Semmelweis University, Department of Psychiatry
🇭🇺Budapest, Hungary
University of Debrecen, Medical and Health Science Centre, Department of Psychiatry
🇭🇺Debrecen, Hungary
University of Pecs, Department of Psychiatry
🇭🇺Pecs, Hungary
SC Lorentina 2102 SRL
🇷🇴Targoviste, Dambovita County, Romania
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #4)
🇷🇺St. Petersburg, Russian Federation
Institution of Russian Academy of Medical Sciences
🇷🇺Tomsk, Russian Federation
Clinical Centre Kragujevac, Psychiatric Clinic
🇷🇸Kragujevac, Serbia
Saint-Petersburg State Healthcare Institution (City Psychiatric Hospital #6)
🇷🇺St. Petersburg, Russian Federation
Municiple Healthcare Institution (City Clinical Hospital #2)
🇷🇺Saratov, Russian Federation
Saint-Petersburg Research Psychoneurogical Institute
🇷🇺St.Petersburg, Russian Federation
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
🇷🇸Vojvodina, Serbia
Institute of Mental Health
🇷🇸Belgrade, Serbia
Odesa Regional Psychiatric Hospital #2
🇺🇦Odesa, Kominternivskyy District, Ukraine
Finger Lakes Clinical Research
🇺🇸Rochester, New York, United States
Synergy Clinical Research Center
🇺🇸National City, California, United States
Excell Research, Inc.
🇺🇸Oceanside, California, United States
CNRI
🇺🇸San Diego, California, United States
Neuro-Behavorial Clinic Research, Inc.
🇺🇸Canton, Ohio, United States
InSite Clinical Research
🇺🇸DeSoto, Texas, United States
Houston Clinical Trials, LLC
🇺🇸Houston, Texas, United States
Alexian Brothers Behavioral Health Hospital
🇺🇸Hoffman Estates, Illinois, United States
FutureSearch Trials of Dallas, L.P.
🇺🇸Dallas, Texas, United States
County Emergency Clinical Hospital of Arad
🇷🇴Arad, Arad County, Romania