SchizophreniaNCT02476877
A Pilot, Proof-of-concept Cohort Study of the Prevalence of Comorbid Mental Illness and Substance Abuse
An observational study of Schizophrenia and Drug Abuse, run by Advanced Clinical Laboratory Solutions, Inc. at 1 site in United States.
Trial summary
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys. Less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Drug Abuse, Anxiety Disorder
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Feb 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female subjects who are aged 18 years and older with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV criteria. Subjects who have multiple psychiatric diagnoses will be excluded from the study.
Who may be able to join
- Subject has granted written informed consent.
- Male or female subject aged 18 years and older.
- Diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV.
- Residents of households, non-institutional group quarters (e.g., shelters, rooming houses, and dormitories), and civilians living on military bases.
Who cannot join
- Subjects younger than 18 years of age.
- Subjects who require a legally authorized representative.
- Subjects who have multiple psychiatric diagnoses.
- Homeless persons who do not use shelters, military personnel on active duty, residents of jails, and residents of institutional group quarters such as hospitals.
- Subjects who are not diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV.
- A medical condition that, in the PI's opinion, could adversely impact the subject's participation or safety, or affect the conduct of the study, or interfere with the urine or oral fluid assessments.
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- Subjects who are terminally ill and/or having an acute/chronic illness such as cancer that will affect their compliance to prescribed medicine.
- Subject who is not able to understand the nature, importance, or consequences of the study.
- Subject who has been treated with an investigational drug, device, or therapy within 30 days prior to screening.
- Subject who has significant or unstable hypertension, vascular disease, or other condition that would interfere with the completion of the study.
- The subject who has a serious or unstable illness or is not in good general health.
Trial locations and contacts
1 site in 1 country.
United States1 site
Advanced Clinical Laboratory Solutions, Inc.
Brooklyn, New York, 11223
About this study
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys. Less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) have on the prevalence of comorbid mental illness and substance abuse also have not been considered. More should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses.
In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).
Read the detailed description
The National Comorbidity Survey Replication (NCS-R), conducted between 2001 and 2003, reported U.S. lifetime prevalence estimates for anxiety disorders (28.8%), mood disorders (20.8%), impulse-control disorders (24.8%), substance use disorders (14.6%), and any disorders (46.4%). Some of these mental conditions start as early as 11 years of age. According to the NCS-R, about half of Americans met or will meet the criteria for a DSM-IV disorder sometime in their life.
The rates for illicit drug use have also been reported. The highest rate of illicit drug use in the U.S. was among 18 to 20 year-olds (23.9%), while the next highest rate occurred among 21-25 year-old adults (19.7%). Males were more likely than females to be users of illicit drugs. As compared to whites (9.2%), rates for illicit drug use were higher among Blacks (11.3%), Native Americans (12.7%) and among persons of two or more ethnic backgrounds (14.8%). Marijuana is the most used drug (18.9 million) followed by pain relievers (6.8 million) and cocaine (1.6 million).
Mental illness surveys have shown that mental disorders are often associated with the risk for substance abuse. The National Survey on Drug Use and Health indicated that, in 2002, approximately 23% (4 million) of adults with serious mental illness were also dependent on or abused alcohol or an illicit drug. However, more than half of the adults (2 million) with co-occurring serious mental illnesses and substance abuse (i.e., comorbidity) received neither mental health nor substance abuse treatment during the previous year.
While the prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys, less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) have on the prevalence of comorbid mental illness and substance abuse have not been considered in detail. Additionally, more should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses.
In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV. The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).
The results of this study will provide new detailed information about the comorbid relationship between specific mental illnesses and substance abuse. Oral fluid and urinalysis screening will provide compliance information (for drugs prescribed for mental illness treatment) and may reveal illicit drug use by their patients.
- Conditions
- Schizophrenia, Drug Abuse, Anxiety Disorder, Bipolar Disorder, Major Depression
- Keywords
- comorbidity, epidemiology, mental illness, drug abuse
- Medical subject headings
- Schizophrenia, Substance-Related Disorders, Anxiety Disorders, Bipolar Disorder, Depressive Disorder, Major, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prescribed-drug treatment group | Eight hundred (800) subjects of which 200 subjects in each of the four mental illnesses will continue to receive prescription drug therapy (as prescribed by their physician/psychiatrist) and counseling to treat their mental illness. | |
| Naïve drug group | Two hundred (200) subjects of which about 50 subjects in each of the four mental illnesses will be initially drug naïve (i.e. currently not taking psychotropic drugs) at the beginning of the study and continue to be drug naïve until the end of the study (6 months) as they receive counseling for their mental illness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of the co-morbidity of mental illness with substance abuse
The primary outcome measure of this study is to determine the prevalence of the co-morbidity of mental illness with substance abuse among a cohort of adults residing in the metropolitan area of New York City. Diagnoses of the four mental illnesses considered in the study (schizophrenia, major depression, bipolar disorder, or anxiety disorder) will be based on DSM-IV criteria. Approximately 1,000 subjects will be enrolled in order to obtain about 3,000 urine or oral fluid samples. Subjects who have multiple psychiatric diagnoses will be excluded from the study.
Measured: 1 year
Secondary outcomes (3)
Association between demographic characteristics and the prevalence of substance abuse in each of the four mental illnesses
A secondary outcome measure is the association between demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) and the prevalence of the co-morbidity of mental illness with substance abuse.
Measured: 1 year
Duration of substance abuse in each of the four mental illnesses
A secondary outcome measure is the duration of substance abuse in each of the four mental illnesses.
Measured: 1 year
Types of drugs associated with each of the four mental illnesses
A secondary outcome measure is the types of drugs that are associated with each of the four mental illnesses.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionJan 2016
- Study completionFeb 2016
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Clinical Laboratory Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonid Reyfman, MD, Principal investigator, Advanced Clinical Laboratory Solutions, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02476877
- Sponsor's protocol ID
- ACLS-COMORBIDITY-001
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2015
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Proof-of-concept Cohort Study of the Prevalence of Comorbid Mental Illness and Substance Abuse
- ClinicalTrials.gov ID
- NCT02476877
- Acronym / sponsor ID
- ACLS-COMORBIDITY-001
- Conditions
- Schizophrenia, Drug Abuse, Anxiety Disorder, Bipolar Disorder, Major Depression
- Keywords
- comorbidity, epidemiology, mental illness, drug abuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Advanced Clinical Laboratory Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 22 Jun 2015 (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.
The prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys. Less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) have on the prevalence of comorbid mental illness and substance abuse also have not been considered. More should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses.
In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV (The Fourth Edition of the Diagnostic and Statistical Manual of Mental Disorders). The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).
Detailed description
The National Comorbidity Survey Replication (NCS-R), conducted between 2001 and 2003, reported U.S. lifetime prevalence estimates for anxiety disorders (28.8%), mood disorders (20.8%), impulse-control disorders (24.8%), substance use disorders (14.6%), and any disorders (46.4%). Some of these mental conditions start as early as 11 years of age. According to the NCS-R, about half of Americans met or will meet the criteria for a DSM-IV disorder sometime in their life.
The rates for illicit drug use have also been reported. The highest rate of illicit drug use in the U.S. was among 18 to 20 year-olds (23.9%), while the next highest rate occurred among 21-25 year-old adults (19.7%). Males were more likely than females to be users of illicit drugs. As compared to whites (9.2%), rates for illicit drug use were higher among Blacks (11.3%), Native Americans (12.7%) and among persons of two or more ethnic backgrounds (14.8%). Marijuana is the most used drug (18.9 million) followed by pain relievers (6.8 million) and cocaine (1.6 million).
Mental illness surveys have shown that mental disorders are often associated with the risk for substance abuse. The National Survey on Drug Use and Health indicated that, in 2002, approximately 23% (4 million) of adults with serious mental illness were also dependent on or abused alcohol or an illicit drug. However, more than half of the adults (2 million) with co-occurring serious mental illnesses and substance abuse (i.e., comorbidity) received neither mental health nor substance abuse treatment during the previous year.
While the prevalence estimates for specific mental disorders and illicit drugs have been separately reported in U.S. government surveys, less is known about the rates for specific comorbid conditions, e.g., schizophrenia and substance abuse, major depression and substance abuse, bipolar disorder and substance abuse, and anxiety disorder and substance abuse. The effects that different demographic characteristics (ethnic background, family medical history, age, living conditions [e.g., living with a single parent]) have on the prevalence of comorbid mental illness and substance abuse have not been considered in detail. Additionally, more should be known about the duration of substance abuse in different mental illnesses among those undergoing treatment, and whether specific types of drugs are associated with specific mental illnesses.
In this study, Advanced Clinical Laboratory Solutions, Inc. will investigate the prevalence rates for the specific comorbid conditions and demographic relationships described above. This multi-site, proof-of-concept cohort study will analyze urine or oral fluid samples from 1,000 subjects diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV. The samples will be analyzed for both prescription drug compliance and illicit substance abuse. Urine or oral fluid samples will be collected at three time points: 1) immediately after enrollment and obtaining informed consent, 2) randomly within 2 to 4 months of the study, and 3) at the end of the study (6 months).
The results of this study will provide new detailed information about the comorbid relationship between specific mental illnesses and substance abuse. Oral fluid and urinalysis screening will provide compliance information (for drugs prescribed for mental illness treatment) and may reveal illicit drug use by their patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prescribed-drug treatment group | – | –Eight hundred (800) subjects of which 200 subjects in each of the four mental illnesses will continue to receive prescription drug therapy (as prescribed by their physician/psychiatrist) and counseling to treat their mental illness. |
| Naïve drug group | – | –Two hundred (200) subjects of which about 50 subjects in each of the four mental illnesses will be initially drug naïve (i.e. currently not taking psychotropic drugs) at the beginning of the study and continue to be drug naïve until the end of the study (6 months) as they receive counseling for their mental illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female subjects who are aged 18 years and older with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV criteria. Subjects who have multiple psychiatric diagnoses will be excluded from the study.
Key inclusion criteria (4 listed)
- Subject has granted written informed consent.
- Male or female subject aged 18 years and older.
- Diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV.
- Residents of households, non-institutional group quarters (e.g., shelters, rooming houses, and dormitories), and civilians living on military bases.
Key exclusion criteria (11 listed)
- Subjects younger than 18 years of age.
- Subjects who require a legally authorized representative.
- Subjects who have multiple psychiatric diagnoses.
- Homeless persons who do not use shelters, military personnel on active duty, residents of jails, and residents of institutional group quarters such as hospitals.
- Subjects who are not diagnosed with one of four mental illnesses (schizophrenia, major depression, bipolar disorder, or anxiety disorder) as determined by DSM-IV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of the co-morbidity of mental illness with substance abuse
Time frame: 1 year
The primary outcome measure of this study is to determine the prevalence of the co-morbidity of mental illness with substance abuse among a cohort of adults residing in the metropolitan area of New York City. Diagnoses of the four mental illnesses considered in the study (schizophrenia, major depression, bipolar disorder, or anxiety disorder) will be based on DSM-IV criteria. Approximately 1,000 subjects will be enrolled in order to obtain about 3,000 urine or oral fluid samples. Subjects who have multiple psychiatric diagnoses will be excluded from the study.
3 secondary outcomes
Association between demographic characteristics and the prevalence of substance abuse in each of the four mental illnesses
Time frame: 1 year
Duration of substance abuse in each of the four mental illnesses
Time frame: 1 year
Types of drugs associated with each of the four mental illnesses
Time frame: 1 year
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 24 Jan 2017.
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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.
Leonid Reyfman, MD principal investigator
Advanced Clinical Laboratory Solutions, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Drug Abuse, run by Advanced Clinical Laboratory Solutions, Inc. 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 4 inclusion and 11 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 24 Jan 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Prevalence of the co-morbidity of mental illness with substance abuse (time frame: 1 year). 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 24 Jan 2017.