Status:
COMPLETED
Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
Lead Sponsor:
Targacept Inc.
Conditions:
Schizophrenia
Negative Symptoms
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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, employm...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
603 Patients enrolled
Trial Details
Trial ID
NCT01488929
Start Date
December 1 2011
End Date
November 1 2013
Last Update
June 3 2015
Active Locations (64)
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1
Collaborative Neuroscience Network, Inc
Garden Grove, California, United States, 92845
2
Behavorial Research Specialists
Glendale, California, United States, 91206
3
Apostle Clinical Trials, Inc
Long Beach, California, United States, 90813
4
Synergy Clinical Research Center
National City, California, United States, 91950