SchizophreniaPhase 2NCT00044083

Clinical Trial of Tolcapone for Cognition in Schizophrenia

A Phase 2 study testing Tolcapone in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well as patients with schizophrenia. Talcapone is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain. ... Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Schizophrenia
What is being tested?: Tolcapone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 210 participants
Where: 1 siteUnited States
Study dates: Aug 2002to Dec 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Prior participation under NIH protocol number 95-M-0150, or new normal volunteers or schizophrenic patients that meet criteria for NIH protocol number 95-M-0150 (NCT00001486).
No Axis I or Axis II diagnosis in normal volunteers.
Age range: 18-50 years.

Who cannot join

Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID interview in Protocol 95-M-0150 or through a screening interview will be excluded.
Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, and untreated or uncontrolled hypertension will be excluded. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Individuals with persistent tardive dyskinesia or abnormal LFTs, or individuals with significant history of alcoholism or liver enzyme elevation will be excluded from the study.
Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded.
Normal control subjects taking any medications other than occasional NSAI will be excluded.
Pregnant women. Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and screened by history for the possibility of pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Tolcapone and Entacapone on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype

...

Read the detailed description

Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of cognitive function. For example, COMT inhibitors can slightly improve working memory/executive function. Differences in the response between individuals might be related to a number of factors, including variations in the genes. The recent finding that a polymorphism in the catechol-o-methyl-transferase (COMT) gene, which produces a 4 fold change in enzyme activity, accounts for 4 percent of the variance in performance of working memory tasks in humans suggest that COMT genotype may predict response to COMT inhibitors. In the present investigation our goal is to examine, in normal controls and patients with schizophrenia, the effect of a centrally acting (tolcapone) and of a peripherally acting (entacapone) COMT inhibitor on cognitive function. We predict that both normal controls and patients with schizophrenia with the val/val genotype will have a significant, though transient, improvement in working memory in subjects treated with tolcapone but not in those treated with entacapone. Furthermore, in conjunction with other NIMH imaging protocols, we would like to examine the neurophysiological correlates related to working memory. We predict, in tolcapone treated subjects, improved measures in prefrontal 'efficiency' in subjects and patients specifically with the val/val genotype. The present protocol will provide new insights on the importance of this genetic polymorphism in the regulation of aminergic-controlled cognitive function in normal individuals. Furthermore, this protocol will test whether COMT inhibitors offer a new treatment-based on genotype - for cognitive impairment in schizophrenia. No IND is required for the present study.

Conditions: Schizophrenia
Being tested: Placebo, Tolcapone
Keywords: Catecholamines, Dopamine, Clinical Trial, fMRI, PFC, Vitamin B2, Riboflavin, Tolcapone, Placebo, Normal Volunteers, Schizophrenia, Healthy Volunteers, HV
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboOther
Placebo: One capsule 3 times a day from Day 1 to Day 7
TolcaponeDrug
Also called Tasmar
Tolcapone: One capsule 3 times a day from Day 1 to Day 7

Study groups in NCT00044083
Study group	Role	What they receive
Placebo Arm	Placebo comparator	Placebo one week Receives: Other: Placebo
Tolcapone Arm	Active comparator	Tolcapone one week Receives: Drug: Tolcapone

What is being measured

The primary outcome is the main question the study is designed to answer.

N-Back Task Performance
Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation Diagnosis Effect
Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p < 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation Drug Effect
Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation in DLPFC in Patients With Schizophrenia
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation in Healthy Volunteers
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation Genotype Effect in Healthy Volunteers
Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p < 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
N-Back Task Activation by Genotype in Patients With Schizophrenia
Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)

Secondary outcomes (1)

Positive and Negative Syndrome Scale
Rating Scales PANSS. The Positive Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The Negative Scale ranges for 7 to 49 with a higher score indicating greater severity of symptoms. The General Scale ranges from 16 to 112, the higher score indicating greater severity of symptoms.
Measured: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2002Dec 2015

First posted19 Aug 2002 (estimated)
Study startAug 2002
Primary completionDec 2015
Study completionDec 2015

Why it stopped: Scientific Director request to use resources for other studies

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 210 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00044083
Sponsor's protocol ID: 020239
Other IDs: 02-M-0239, NCT00044083
Status last verified: Mar 2018
First submitted: 16 Aug 2002
Last updated: 27 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: No plan to share data

Publications

Aksoy S, Klener J, Weinshilboum RM. Catechol O-methyltransferase pharmacogenetics: photoaffinity labelling and western blot analysis of human liver samples. Pharmacogenetics. 1993 Apr;3(2):116-22. doi: 10.1097/00008571-199304000-00008.
PubMed 8518836
Andreasen NC, Arndt S, Cizadlo T, O'Leary DS, Watkins GL, Ponto LL, Hichwa RD. Sample size and statistical power in [15O]H2O studies of human cognition. J Cereb Blood Flow Metab. 1996 Sep;16(5):804-16. doi: 10.1097/00004647-199609000-00005.
PubMed 8784225
Arnsten AF. Catecholamine regulation of the prefrontal cortex. J Psychopharmacol. 1997;11(2):151-62. doi: 10.1177/026988119701100208.
PubMed 9208378
Magalona SC, Rasetti R, Chen J, Chen Q, Gold I, Decot H, Callicott JH, Berman KF, Apud JA, Weinberger DR, Mattay VS. Effect of tolcapone on brain activity during a variable attentional control task: a double-blind, placebo-controlled, counter-balanced trial in healthy volunteers. CNS Drugs. 2013 Aug;27(8):663-73. doi: 10.1007/s40263-013-0082-x.
PubMed 23794107

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Tolcapone and Entacapone on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype
ClinicalTrials.gov ID: NCT00044083
Acronym / sponsor ID: 020239
Conditions: Schizophrenia
Keywords: Catecholamines, Dopamine, Clinical Trial, fMRI, PFC, Vitamin B2, Riboflavin, Tolcapone
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Scientific Director request to use resources for other studies
Enrolment: 210 participants (actual)
Lead sponsor: National Institute of Mental Health (NIMH)US National Institutes of Health
Study start: Aug 2002
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 19 Aug 2002 (estimated)
Results: Posted 17 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

...

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Placebo Arm	Placebo comparator	Other: PlaceboPlacebo one week
Tolcapone Arm	Active comparator	Drug: TolcaponeTolcapone one week

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Key exclusion criteria (5 listed)

Normal volunteers with an Axis I or Axis II disorder obtained either from prior SCID interview in Protocol 95-M-0150 or through a screening interview will be excluded.
Subjects with a history of cardiovascular disease, liver disease and other medical illnesses, and untreated or uncontrolled hypertension will be excluded. An electrocardiogram, blood pressure, pulse rate and metabolic panel including LFTs will be checked on all subjects prior to participation in the study. Individuals with persistent tardive dyskinesia or abnormal LFTs, or individuals with significant history of alcoholism or liver enzyme elevation will be excluded from the study.
Schizophrenic patients taking clozapine, a COMT inhibitor, any illicit drugs of abuse, or MAO inhibitors will be excluded.
Normal control subjects taking any medications other than occasional NSAI will be excluded.
Pregnant women. Women of childbearing potential will undergo a urine pregnancy test the day the study initiates and screened by history for the possibility of pregnancy.

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
PlaceboPlacebo: One capsule 3 times a day from Day 1 to Day 7	Other	Placebo Arm
TolcaponeAlso: TasmarTolcapone: One capsule 3 times a day from Day 1 to Day 7	Drug	Tolcapone Arm

Primary outcome

N-Back Task Performance
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Working Memory was measured in HVs and patients with schizophrenia after a 7-day treatment with Tolcapone or placebo in a double-blind, cross-over fashion. The working memory was quantified by taking the number of trials entered correctly divided by the total number of trials multiplied by 100. Values range from 0 to 100. Zero indicates the poorest performance while 100 indicates perfect performance.
N-Back Task Activation Diagnosis Effect
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation beta values (N-Back vs. 0-Back) were extracted within the Main Effect of Diagnosis cluster around the peak (p < 0.05 uncorrected) from the contrast maps in the Placebo condition. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
N-Back Task Activation Drug Effect
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation beta values (N-Back vs. 0-Back) extracted within the Main Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps across both groups. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
N-Back Task Activation in DLPFC in Patients With Schizophrenia
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
N-Back Task Activation in Healthy Volunteers
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation Beta values (N-Back vs. 0-Back) extracted within the Effect of Drug cluster around the peak (p < 0.05 uncorrected) from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
N-Back Task Activation Genotype Effect in Healthy Volunteers
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation beta values (N-Back vs. 0-Back) extracted within the Effect of Genotype cluster around the peak (p < 0.05 uncorrected) in right and left DLPFC from the contrast maps in Healthy Volunteers. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.
N-Back Task Activation by Genotype in Patients With Schizophrenia
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)
Activation beta values (N-Back vs. 0-Back) extracted from DLPFC from the contrast maps in Patients with schizophrenia. Lower beta values reflect more efficient processing in the DLPFC when performing working memory tasks.

1 secondary outcome

Positive and Negative Syndrome Scale
Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)

Results and safety

Results posted to the registry on 17 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First Then Tolcapone	74	64
Tolcapone First, Then Placebo	73	66

Primary outcome: N-Back Task Performance

Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention). Mean (Standard Error). Unit: % of Correct Trials

Measure	Healthy Volunteer on Placebo n = 74	Healthy Volunteer Tolcapone n = 74	Patient on Placebo n = 33	Patients on Tolcapone n = 33
Value	86.10 (1.13)	85.50 (1.10)	76.21 (2.31)	80.94 (1.90)

Healthy Volunteer on Placebo vs Patient on Placebo: p <0.0001, ANOVA
Patient on Placebo vs Patients on Tolcapone: p = 0.0034, ANOVA

Population analysed: 147 HV's recruited, 8 left after signing consents, 8 excluded for other reasons, 57 excluded for excessive motion, inferior quality or not completion. 63 patients recruited, 4 removed for different reasons, 26 excluded from image analyses for not completing the second phase of the study, excessive motion or bad image quality.

Primary outcome: N-Back Task Activation Diagnosis Effect

Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention). Mean (Standard Error). Unit: beta value

Measure	Healthy Volunteer on Placebo n = 74	Patient on Placebo n = 33
Right DLPFC	0.15 (0.02)	0.20 (0.03)
Left DLPFC	0.18 (0.02)	0.23 (0.03)

Healthy Volunteer on Placebo vs Patient on Placebo: p <0.0001, ANOVA
Healthy Volunteer on Placebo vs Patient on Placebo: p = 0.014, ANOVA

Population analysed: 74 Healthy Volunteers and 33 Patients with Schizophrenia

Primary outcome: N-Back Task Activation Drug Effect

Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention). Mean (Standard Error). Unit: beta value

Measure	Healthy Volunteers on Placebo n = 74	Healthy Volunteers on Tolcapone n = 74	Patients on Placebo n = 33	Patients on Tolcapone n = 33
Right DLPFC	0.09 (0.03)	0.11 (0.02)	0.12 (0.04)	0.07 (0.03)
Left DLPFC	0.27 (0.04)	0.25 (0.04)	0.23 (0.05)	0.09 (0.06)

Healthy Volunteers on Placebo vs Healthy Volunteers on Tolcapone vs Patients on Placebo vs Patients on Tolcapone: p = 0.05, ANOVA
Healthy Volunteers on Placebo vs Healthy Volunteers on Tolcapone vs Patients on Placebo vs Patients on Tolcapone: p = 0.32, ANOVA

Population analysed: 74 Healthy Volunteers and 33 Patients with Schizophrenia

Primary outcome: N-Back Task Activation in DLPFC in Patients With Schizophrenia

Time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention). Mean (Standard Error). Unit: beta value

Measure	Patients on Placebo n = 33	Patients on Tolcapone n = 33
Right DLPFC	0.26 (0.02)	0.24 (0.018)
Left DLPFC	0.25 (0.02)	0.23 (0.02)

Patients on Placebo vs Patients on Tolcapone: p = 0.05, t-test, 1 sided
Patients on Placebo vs Patients on Tolcapone: p = 0.078, t-test, 1 sided

Population analysed: 33 Patients with Schizophrenia

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Day 1 to Day 21. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Volunteers on Placebo	0 of 131 (0%)	25 of 131 (19.1%)	0 of 131
Healthy Volunteers on Tolcapone	0 of 131 (0%)	29 of 131 (22.1%)	0 of 131
Patients on Placebo	0 of 59 (0%)	17 of 59 (28.8%)	0 of 59
Patients on Tolcapone	0 of 60 (0%)	22 of 60 (36.7%)	0 of 60

Limitations and caveats (from the sponsor): There was an early termination due to a request from the NIMH leadership to assess if was justifiable to continue when considering costs of this research and needs to assess resources to develop new protocols for the Branch

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8518836Aksoy S, Klener J, Weinshilboum RM. Catechol O-methyltransferase pharmacogenetics: photoaffinity labelling and western blot analysis of human liver samples. Pharmacogenetics. 1993 Apr;3(2):116-22. doi: 10.1097/00008571-199304000-00008.
Background: PubMed 8784225Andreasen NC, Arndt S, Cizadlo T, O'Leary DS, Watkins GL, Ponto LL, Hichwa RD. Sample size and statistical power in [15O]H2O studies of human cognition. J Cereb Blood Flow Metab. 1996 Sep;16(5):804-16. doi: 10.1097/00004647-199609000-00005.
Background: PubMed 9208378Arnsten AF. Catecholamine regulation of the prefrontal cortex. J Psychopharmacol. 1997;11(2):151-62. doi: 10.1177/026988119701100208.
Derived from this study: PubMed 23794107Magalona SC, Rasetti R, Chen J, Chen Q, Gold I, Decot H, Callicott JH, Berman KF, Apud JA, Weinberger DR, Mattay VS. Effect of tolcapone on brain activity during a variable attentional control task: a double-blind, placebo-controlled, counter-balanced trial in healthy volunteers. CNS Drugs. 2013 Aug;27(8):663-73. doi: 10.1007/s40263-013-0082-x.
NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Individual participant dataSharing planned: No. No plan to share data

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

Jose A Apud, M.D. principal investigator

National Institute of Mental Health (NIMH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tolcapone in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 1 site in United States.

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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

N-Back Task Performance (time frame: At end of treatment period (at 7th day for first intervention and at 21st day for second intervention)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00044083, which also lists 4 linked publications.

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 27 Sep 2018.