SchizophreniaPhase 2NCT01488929
Efficacy, Safety, and Tolerability of TC-5619 as Augmentation Therapy to Improve Negative Symptoms and Cognition in Outpatients With Schizophrenia
A Phase 2 study testing TC-5619 in people with Schizophrenia and Negative Symptoms, run by Targacept Inc. at 64 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Negative Symptoms, Cognitive Dysfunction
- What is being tested?
- TC-5619
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 603 participants
- Where
- 64 sitesin 6 countries
- Study dates
- Dec 2011to Nov 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
64 sites in 6 countries.
64 sites in 6 countries
United States22 sites
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
Behavioral Medical Research
Brooklyn, New York, 11241
Neuro-Behavorial Clinic Research, Inc.
Canton, Ohio, 44718
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
InSite Clinical Research
DeSoto, Texas, 75115
Precise Research Group
Flowood, Mississippi, 39232
Collaborative Neuroscience Network, Inc
Garden Grove, California, 92845
Behavorial Research Specialists
Glendale, California, 91206
Alexian Brothers Behavioral Health Hospital
Hoffman Estates, Illinois, 60169
Houston Clinical Trials, LLC
Houston, Texas, 77098
Segal Institute for Clinical Research
Lauderhill, Florida, 33319
Compass Research, LLC
Leesburg, Florida, 34749
Apostle Clinical Trials, Inc
Long Beach, California, 90813
CRI Worldwide, LLC
Marlton, New Jersey, 08053
Synergy Clinical Research Center
National City, California, 91950
Excell Research, Inc.
Oceanside, California, 92056
Neuropsychiatric Research Center of Orange County
Orange, California, 92868
Finger Lakes Clinical Research
Rochester, New York, 14618
St. Charles Psychiatric Associates - Midwest Reserch Group
Saint Charles, Missouri, 63304
CNRI
San Diego, California, 92102
PsychCare Consultants Research
St Louis, Missouri, 63128
Russia14 sites
Kemerovo Regional Clinical Psychiatric Hospital
Kemerovo, 650036
Moscow Research Institute of Psychiatry
Moscow, 107076
Menthal Health Research Center of the RAMS
Moscow, 115522
Nizhniy Novgorod Regional Psychoneurological Hospital # 1
Nizhny Novgorod, 603152
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #7)
Saint Petersburg, 190005
Saint-Petersburg State Public Healthcare Institution (Saint Nicholas Psychiatric Hospital)
Saint Petersburg, 190121
Saint-Petersburg State Public Healthcare Institution (City Psychiatric Hospital #4)
Saint Petersburg, 191119
Saint-Petersburg Research Psychoneurogical Institute
Saint Petersburg, 192019
Saint-Petersburg State Healthcare Institution (City Psychiatric Hospital #6)
Saint Petersburg, 193167
Municiple Healthcare Institution (City Clinical Hospital #2)
Saratov, 410028
Institution of Russian Academy of Medical Sciences
Tomsk, 634014
Nizhny Novgorod Region State Budgetary Institution of Healthcare "Clinical Psychiatric Hospital #1 of Nizhny Novgorod"
Velikiy Novgorod, 603155
Yaroslavl State Medical Academy, Department of Psychiatry
Yaroslavl, 150003
Regional State Healthcare Institution (Sverdlovsk Regional Clinical Psychiatric Hospital)
Yekaterinburg, 620030
Ukraine12 sites
Dnipropetrovsk Regional Clinical Hospital
Dnipropetrovsk, 49005
Dnipropetrovsk State Medical Academy, Dept. of Psychiatry
Dnipropetrovsk, 49115
Donetsk National Medical University (Regional Clinical Psychiatric Hospital)
Donetsk, 83008
Institute of Neurology, Psychiatry and Narcology AMS of Ukraine
Kharkiv, 61068
Kharkiv Regional Clinical Psychiatric Hospital N 3
Kharkiv, 61068
Kyiv Station Railway Clinical Hospital # 1 of the STBA "South-Western Railway"
Kyiv, 01030
Lugansk State Medical University
Luhansk, 91045
Odesa Regional Psychiatric Hospital #2
Odesa, Kominternivskyy District, 67513
Odesa Regional Psychoneurological Dispensary
Odesa, 65014
Ukrainian Medical Stomatological Academy, Dept. of Psychiatry
Poltava, 36013
Crimean State Medical University (Dept. of Psychiatry)
Simferopol, Autonomous Republic of Crimea, 95006
Vinnytsya National Medical University, Dept. of Psychiatry & Narcology
Vinnytsia, 21018
Serbia6 sites
Clinical Centre "Dr Dragisa Misovic", Clinic of Psychiatry
Belgrade, 11000
Clinical Centre of Serbia, Clinic of Psychiatry
Belgrade, 11000
Institute of Mental Health
Belgrade, 11000
Clinical Centre Nis, Psychiatric Clinic
Gornja Toponica, 18202
Clinical Centre Kragujevac, Psychiatric Clinic
Kragujevac, 34000
Special Hospital for Psychiatric Diseases "Sveti Vracevi"
Vojvodina, 23330
Hungary5 sites
Semmelweis University, Department of Psychiatry
Budapest, 1083
University of Debrecen, Medical and Health Science Centre, Department of Psychiatry
Debrecen, 4032
Pharma4Trial Kft.
Gyöngyös, 3200
University of Pecs, Department of Psychiatry
Pécs, 7600
St. George Hospital, Department of Psychiatry
Székesfehérvár, 8000
Romania5 sites
County Emergency Clinical Hospital of Arad
Arad, Arad, 310022
CMDTA Neomed
Brasov, Brașov County, 500283
University Emergency Central Military Hospital, Dept. of Psychiatry
Bucharest, 010816
Neuropsychiatry Clinical Hospital Craiova, Psychiatry Department
Craiova, Dolj, 200473
SC Lorentina 2102 SRL
Targoviste, Dâmbovița County, 130081
About this study
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
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.
- Conditions
- Schizophrenia, Negative Symptoms, Cognitive Dysfunction
- Being tested
- TC-5619, Placebo
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TC-5619Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 5 mg TC-5619 | Experimental | One tablet of 5 mg TC-5619 will be administered orally once a day. Receives: Drug: TC-5619 |
| 50 mg TC-5619 | Experimental | One tablet of 50 mg TC-5619 will be administered orally once a day. Receives: Drug: TC-5619 |
| Placebo | Placebo comparator | One tablet of placebo will be administered orally once a day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Scale for Assessment of Negative Symptoms (SANS)
Measured: 24 weeks
Secondary outcomes (2)
Change from baseline in the Cogstate Schizophrenia Battery (CSB)
Measured: 24 weeks
Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David P Walling, PhD, Principal investigator, Collaborative Neuroscience Network, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488929
- Sponsor's protocol ID
- TC-5619-23-CRD-003
- Status last verified
- Dec 2013
- First submitted
- 6 Dec 2011
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01488929
- Acronym / sponsor ID
- TC-5619-23-CRD-003
- Conditions
- Schizophrenia, Negative Symptoms, Cognitive Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 8 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 mg TC-5619 | Experimental | Drug: TC-5619One tablet of 5 mg TC-5619 will be administered orally once a day. |
| 50 mg TC-5619 | Experimental | Drug: TC-5619One tablet of 50 mg TC-5619 will be administered orally once a day. |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet of placebo will be administered orally once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TC-5619 | Drug | 5 mg TC-5619, 50 mg TC-5619 |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in the Scale for Assessment of Negative Symptoms (SANS)
Time frame: 24 weeks
2 secondary outcomes
Change from baseline in the Cogstate Schizophrenia Battery (CSB)
Time frame: 24 weeks
Change from baseline in UCSD Performance Based Skills Assessment, brief version (UPSA-Brief)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David P Walling, PhD principal investigator
Collaborative Neuroscience Network, Inc
64 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TC-5619 in people with Schizophrenia and Negative Symptoms, run by Targacept Inc. at 64 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in United States, Russia, Ukraine, Serbia, Hungary and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Scale for Assessment of Negative Symptoms (SANS) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.