Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
This study has been completed.
Information provided by (Responsible Party):
First received: December 6, 2011
Last updated: December 6, 2013
Last verified: December 2013
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||A Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study to Assess Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
Primary Outcome Measures:
- Change from baseline in the Scale for Assessment of Negative Symptoms (SANS) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in the Cogstate Schizophrenia Battery (CSB) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Experimental: 5 mg TC-5619
One tablet of 5 mg TC-5619 will be administered orally once a day.
Experimental: 50 mg TC-5619
One tablet of 50 mg TC-5619 will be administered orally once a day.
Placebo Comparator: Placebo
One tablet of placebo will be administered orally once a day.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01488929
||David P Walling, PhD
||Collaborative Neuroscience Network, Inc
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 6, 2011
||December 6, 2013
||United States: Food and Drug Administration
Romania: National Medicines Agency
Ukraine: Ministry of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Schizophrenia and Disorders with Psychotic Features
Delirium, Dementia, Amnestic, Cognitive Disorders