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

Sponsor
Targacept Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01488929
Collaborator
(none)
603
Enrollment
64
Locations
3
Arms
23
Duration (Months)
9.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
603 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Dec 1, 2011
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: 5 mg TC-5619

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

Drug: TC-5619
Experimental: 50 mg TC-5619

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

Drug: TC-5619
Placebo Comparator: Placebo

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

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in the Scale for Assessment of Negative Symptoms (SANS) [24 weeks]

Secondary Outcome Measures

  1. Change from baseline in the Cogstate Schizophrenia Battery (CSB) [24 weeks]

  2. Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief) [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Diagnosis of schizophrenia, per DSM-IV-TR criteria, as aided by the MINI International Neuropsychiatric Interview

  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:

  1. Diagnosis of schizoaffective or schizophreniform disorders within 1 year prior to Screening.

  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.

Contacts and Locations

Locations

Site City State Country Postal Code
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
5 Excell Research, Inc. Oceanside California United States 92056
6 Neuropsychiatric Research Center of Orange County Orange California United States 92868
7 CNRI San Diego California United States 92102
8 Segal Institute for Clinical Research Lauderhill Florida United States 33319
9 Compass Research, LLC Leesburg Florida United States 34749
10 Atlanta Center for Medical Research Atlanta Georgia United States 30308
11 Alexian Brothers Behavioral Health Hospital Hoffman Estates Illinois United States 60169
12 Precise Research Group Flowood Mississippi United States 39232
13 St. Charles Psychiatric Associates - Midwest Reserch Group Saint Charles Missouri United States 63304
14 PsychCare Consultants Research St. Louis Missouri United States 63128
15 CRI Worldwide, LLC Marlton New Jersey United States 08053
16 Behavioral Medical Research Brooklyn New York United States 11241
17 Finger Lakes Clinical Research Rochester New York United States 14618
18 Neuro-Behavorial Clinic Research, Inc. Canton Ohio United States 44718
19 Midwest Clinical Research Center Dayton Ohio United States 45417
20 FutureSearch Trials of Dallas, L.P. Dallas Texas United States 75231
21 InSite Clinical Research DeSoto Texas United States 75115
22 Houston Clinical Trials, LLC Houston Texas United States 77098
23 Semmelweis University, Department of Psychiatry Budapest Hungary 1083
24 University of Debrecen, Medical and Health Science Centre, Department of Psychiatry Debrecen Hungary 4032
25 Pharma4Trial Kft. Gyongyos Hungary 3200
26 University of Pecs, Department of Psychiatry Pecs Hungary 7600
27 St. George Hospital, Department of Psychiatry Szekesfehervar Hungary 8000
28 County Emergency Clinical Hospital of Arad Arad Arad County Romania 310022
29 CMDTA Neomed Brasov Brasov County Romania 500283
30 SC Lorentina 2102 SRL Targoviste Dambovita County Romania 130081
31 Neuropsychiatry Clinical Hospital Craiova, Psychiatry Department Craiova Dolj County Romania 200473
32 University Emergency Central Military Hospital, Dept. of Psychiatry Bucharest Romania 010816
33 Kemerovo Regional Clinical Psychiatric Hospital Kemerovo Russian Federation 650036
34 Moscow Research Institute of Psychiatry Moscow Russian Federation 107076
35 Menthal Health Research Center of the RAMS Moscow Russian Federation 115522
36 Nizhniy Novgorod Regional Psychoneurological Hospital # 1 Nizhniy Novgorod Russian Federation 603152
37 Nizhny Novgorod Region State Budgetary Institution of Healthcare "Clinical Psychiatric Hospital #1 of Nizhny Novgorod" Novgorod Russian Federation 603155
38 Municiple Healthcare Institution (City Clinical Hospital #2) Saratov Russian Federation 410028
39 Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #7) St. Petersburg Russian Federation 190005
40 Saint-Petersburg State Public Healthcare Institution (Saint Nicholas Psychiatric Hospital) St. Petersburg Russian Federation 190121
41 Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #4) St. Petersburg Russian Federation 191119
42 Saint-Petersburg State Healthcare Institution (City Psychiatric Hospital #6) St. Petersburg Russian Federation 193167
43 Saint-Petersburg Research Psychoneurogical Institute St.Petersburg Russian Federation 192019
44 Institution of Russian Academy of Medical Sciences Tomsk Russian Federation 634014
45 Yaroslavl State Medical Academy, Department of Psychiatry Yaroslavl Russian Federation 150003
46 Regional State Healthcare Institution (Sverdlovsk Regional Clinical Psychiatric Hospital) Yekaterinburg Russian Federation 620030
47 Clinical Centre "Dr Dragisa Misovic", Clinic of Psychiatry Belgrade Serbia 11000
48 Clinical Centre of Serbia, Clinic of Psychiatry Belgrade Serbia 11000
49 Institute of Mental Health Belgrade Serbia 11000
50 Clinical Centre Nis, Psychiatric Clinic Gornja Toponica Serbia 18202
51 Clinical Centre Kragujevac, Psychiatric Clinic Kragujevac Serbia 34000
52 Special Hospital for Psychiatric Diseases "Sveti Vracevi" Vojvodina Serbia 23330
53 Crimean State Medical University (Dept. of Psychiatry) Simferopol Autonomous Republic of Crimea Ukraine 95006
54 Odesa Regional Psychiatric Hospital #2 Odesa Kominternivskyy District Ukraine 67513
55 Dnipropetrovsk Regional Clinical Hospital Dnipropetrovsk Ukraine 49005
56 Dnipropetrovsk State Medical Academy, Dept. of Psychiatry Dnipropetrovsk Ukraine 49115
57 Donetsk National Medical University (Regional Clinical Psychiatric Hospital) Donetsk Ukraine 83008
58 Institute of Neurology, Psychiatry and Narcology AMS of Ukraine Kharkiv Ukraine 61068
59 Kharkiv Regional Clinical Psychiatric Hospital N 3 Kharkiv Ukraine 61068
60 Kyiv Station Railway Clinical Hospital # 1 of the STBA "South-Western Railway" Kyiv Ukraine 01030
61 Lugansk State Medical University Lugansk Ukraine 91045
62 Odesa Regional Psychoneurological Dispensary Odesa Ukraine 65014
63 Ukrainian Medical Stomatological Academy, Dept. of Psychiatry Poltava Ukraine 36013
64 Vinnytsya National Medical University, Dept. of Psychiatry & Narcology Vinnytsya Ukraine 21018

Sponsors and Collaborators

  • Targacept Inc.

Investigators

  • Principal Investigator: David P Walling, PhD, Collaborative Neuroscience Network, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Targacept Inc.
ClinicalTrials.gov Identifier:
NCT01488929
Other Study ID Numbers:
  • TC-5619-23-CRD-003
First Posted:
Dec 8, 2011
Last Update Posted:
Jun 3, 2015
Last Verified:
Dec 1, 2013
Additional relevant MeSH terms:
Schizophrenia
Cognitive Dysfunction

Study Results

No Results Posted as of Jun 3, 2015