SchizophreniaPhase 4COATSNCT00802100
Comparison of Optimal Antipsychotic Treatments for Adults With Schizophrenia
A Phase 4 study testing Olanzapine, Perphenazine and Aripiprazole in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 13 sites in United States.
Trial summary
This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine, Perphenazine and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2008to Oct 2009
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
- Treated with antipsychotic medication for less than 5 years
- Adequate decisional capacity to make a choice about participating in this research study. Adequate decisional capacity will be determined through the aid of a 10-item decisional capacity quiz adapted from the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC) scale.
- Psychotic exacerbation within the month prior to study entry that required psychiatric hospitalization or an increased level of care
- Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices; or barrier methods, such as condoms, diaphragm, and spermicides.
Who cannot join
- Body mass index at or above 35 kg/m2 or below 18 kg/m2
- Hemoglobin A1c level at or above 7%
- Hematocrit level at or above 31%
- Non-high density lipoprotein cholesterol at or above 190 mg/dL
- Triglycerides at or above 500 mg/dL
- Documented failure, defined as inefficacy or intolerability, with an adequate trial of olanzapine, perphenazine, or aripiprazole. Adequate trials last at least 4 weeks at a minimum dose of 15 mg/day of aripiprazole, 15 mg/day of olanzapine, or 16 mg/day of perphenazine.
Show all 21Show fewer
- Current treatment with olanzapine, perphenazine, or aripiprazole for more than 1 month
- Known hypersensitivity to metformin, simvastatin, or benztropine
- Treatment with a medication prescribed for weight loss
- Diagnosis of diabetes mellitus or treatment with insulin or other diabetes medication
- Contraindications to metformin use, including any of the following:
- Diagnosis of congestive heart failure
- Renal impairment, defined as serum creatinine at or above 1.5 in males and 1.4 in females, or creatinine estimated glomerular filtration rate (GFR) outside of normal limits
- Hepatic disease, defined as aspartate transaminase (AST), alanine transaminase (ALT), or c-glutamyl transferase (CGT) more than 1.5 times upper limit of normal (ULN) or total bilirubin more than 1.2 times ULN
- Metabolic acidosis, defined as a serum CO2 level less than the lower limit of normal
- Recent (in the past 30 days) or scheduled radiological studies involving iodinated contrast material
- Alcohol abuse or dependence, as determined by SCID within the past month
- Concurrent treatment with certain drugs known to increase metformin blood levels
- Any unstable or serious medical condition, as judged by the investigator
- Pregnant or breastfeeding
- Diagnosis of mental retardation or delirium, as defined by the DSM-IV-TR
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Medical College of Georgia
Augusta, Georgia, 30912
Duke University Medical Center-John Umstead Hospital
Butner, North Carolina, 27509
SHANTI Clinical Trials
Colton, California, 92324
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
Wayne State University
Detroit, Michigan, 48201
Clinical Insights
Glen Burnie, Maryland, 21061
Baylor College of Medicine
Houston, Texas, 77030
University of Miami School of Medicine
Miami, Florida, 33316
University of Minnesota School of Medicine
Minneapolis, Minnesota, 55454
Yale University
New Haven, Connecticut, 06519
Research Foundation for Mental Hygiene
New York, New York, 10032
Stanford University
Palo Alto, California, 94305
University of Massachusetts
Worcester, Massachusetts, 01605
About this study
Official title: Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study
This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia.
Read the detailed description
Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief from some of the most common severe side effects. This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of additional medications to limit treatment side effects, in adults with schizophrenia.
Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic. Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline measurements. The screening visit will take place at study entry, and the baseline visit will take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the baseline visit, followed by monthly visits.
At the baseline visit participants will be randomly assigned to receive olanzapine, perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications will start at low levels and be increased to full strength over 2 weeks. If participants are taking another antipsychotic when they enter the study, this 2-week period will also be used to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all three antipsychotics will be monitored, and, depending on the side effect, one of three different medications will be added to the treatment regimen. If increased cholesterol levels are experienced with any antipsychotic, simvastatin will be added; if weight gain is experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle stiffness are experienced, benztropine will be added. Because of already known side effects, participants assigned to olanzapine or perphenazine will automatically add metformin or benztropine, respectively, to their regimens.
Starting on the third study visit, participants will also undergo a behavioral treatment aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine 20-minute sessions, with phone calls being made to participants between sessions.
During each study visit, assessments will be made of schizophrenia symptoms, side effects, adherence to medication regimen, vital signs, waist circumference, and weight. Participants will also complete a questionnaire on use of health care services and undergo instructions on exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab tests. Additional measures at the screening visit will include questions about medical and psychiatric history, a urine test for drugs, and a questionnaire about physical and social activities.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Perphenazine, Aripiprazole, Metformin, Simvastatin
- Keywords
- Schizoaffective Disorder
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Zyprexa
Daily tablets of 10 to 30 mg
PerphenazineDrug
Also called Trilafon
Daily tablets of 8 to 24 mg
AripiprazoleDrug
Also called Abilify
Daily tablets of 10 to 30 mg
MetforminDrug
Also called Glucophage
Daily tablets of 850 to 2550 mg
SimvastatinDrug
Also called Zocor
Daily tablets of 20 to 40 mg
BenztropineDrug
Also called Cogentin
Daily tablets of 1 to 2 mg
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Experimental | Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects. Receives: Drug: Olanzapine; Drug: Metformin; Drug: Simvastatin; Drug: Benztropine |
| Perphenazine | Experimental | Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects. Receives: Drug: Perphenazine; Drug: Metformin; Drug: Simvastatin; Drug: Benztropine |
| Aripiprazole | Experimental | Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects. Receives: Drug: Aripiprazole; Drug: Metformin; Drug: Simvastatin; Drug: Benztropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study
Goal was to randomize 60 participants who met eligibility criteria.
Measured: Baseline
Secondary outcomes (1)
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Measured: Measured over 28 weeks of study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionOct 2009
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Marvin Swartz, MD, Principal investigator, Duke UniversityT. Scott Stroup, MD, MPH, Principal investigator, University of North Carolina, Chapel HillJoseph P. McEvoy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802100
- Sponsor's protocol ID
- N01 MH090001-02
- Other IDs
- N01MH90001, N01MH090001
- Acronym
- COATS
- Status last verified
- Apr 2012
- First submitted
- 3 Dec 2008
- Last updated
- 8 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Optimal Antipsychotic Treatments for Schizophrenia Pilot Study
- ClinicalTrials.gov ID
- NCT00802100
- Acronym / sponsor ID
- COATS / N01 MH090001-02
- Conditions
- Schizophrenia
- Keywords
- Schizoaffective Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Posted 8 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of other medications to limit treatment side effects, in adults with schizophrenia.
Detailed description
Schizophrenia is a chronic brain disease affecting approximately 1% of Americans. Antipsychotic medications can treat some of the most severe symptoms of schizophrenia, but they are not a cure, are often taken for long periods of time, and can have severe side effects. Other, secondary medications can provide relief from some of the most common severe side effects. This study will compare the safety and effectiveness of three different antipsychotic medications, as well as the use of additional medications to limit treatment side effects, in adults with schizophrenia.
Participation in this study will last 28 to 30 weeks and include 11 visits to a study clinic. Each visit will last 2 to 3 hours. The first 2 visits will include screening and baseline measurements. The screening visit will take place at study entry, and the baseline visit will take place 3 to 14 days later. Study visits will then occur 1, 2, and 4 weeks after the baseline visit, followed by monthly visits.
At the baseline visit participants will be randomly assigned to receive olanzapine, perphenazine, or aripiprazole for 28 weeks. Dosage for all three antipsychotic medications will start at low levels and be increased to full strength over 2 weeks. If participants are taking another antipsychotic when they enter the study, this 2-week period will also be used to slowly reduce and then end treatment with the non-study antipsychotic. Side effects to all three antipsychotics will be monitored, and, depending on the side effect, one of three different medications will be added to the treatment regimen. If increased cholesterol levels are experienced with any antipsychotic, simvastatin will be added; if weight gain is experienced, metformin will be added; if involuntary movements, inner restlessness, or muscle stiffness are experienced, benztropine will be added. Because of already known side effects, participants assigned to olanzapine or perphenazine will automatically add metformin or benztropine, respectively, to their regimens.
Starting on the third study visit, participants will also undergo a behavioral treatment aimed at reducing cardiovascular risk factors. This behavioral treatment will involve nine 20-minute sessions, with phone calls being made to participants between sessions.
During each study visit, assessments will be made of schizophrenia symptoms, side effects, adherence to medication regimen, vital signs, waist circumference, and weight. Participants will also complete a questionnaire on use of health care services and undergo instructions on exercise and eating right. On visits 1, 5, 7, and 11, blood will be drawn for standard lab tests. Additional measures at the screening visit will include questions about medical and psychiatric history, a urine test for drugs, and a questionnaire about physical and social activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Experimental | Drug: Olanzapine, Drug: Metformin, Drug: Simvastatin, Drug: BenztropineParticipants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects. |
| Perphenazine | Experimental | Drug: Perphenazine, Drug: Metformin, Drug: Simvastatin, Drug: BenztropineParticipants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects. |
| Aripiprazole | Experimental | Drug: Aripiprazole, Drug: Metformin, Drug: Simvastatin, Drug: BenztropineParticipants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of schizophrenia or schizoaffective disorder, as defined by DSM-IV-TR criteria and confirmed by the Structured Clinical Interview for DSM-IV (SCID)
- Treated with antipsychotic medication for less than 5 years
- Adequate decisional capacity to make a choice about participating in this research study. Adequate decisional capacity will be determined through the aid of a 10-item decisional capacity quiz adapted from the University of California, San Diego, Brief Assessment of Capacity to Consent (UBACC) scale.
- Psychotic exacerbation within the month prior to study entry that required psychiatric hospitalization or an increased level of care
- Willing to use an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study. Acceptable methods include oral, injectable, or implanted contraceptives; intrauterine devices; or barrier methods, such as condoms, diaphragm, and spermicides.
Key exclusion criteria (21 listed)
- Body mass index at or above 35 kg/m2 or below 18 kg/m2
- Hemoglobin A1c level at or above 7%
- Hematocrit level at or above 31%
- Non-high density lipoprotein cholesterol at or above 190 mg/dL
- Triglycerides at or above 500 mg/dL
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 |
|---|---|---|
| OlanzapineAlso: ZyprexaDaily tablets of 10 to 30 mg | Drug | Olanzapine |
| PerphenazineAlso: TrilafonDaily tablets of 8 to 24 mg | Drug | Perphenazine |
| AripiprazoleAlso: AbilifyDaily tablets of 10 to 30 mg | Drug | Aripiprazole |
| MetforminAlso: GlucophageDaily tablets of 850 to 2550 mg | Drug | Aripiprazole, Olanzapine, Perphenazine |
| SimvastatinAlso: ZocorDaily tablets of 20 to 40 mg | Drug | Aripiprazole, Olanzapine, Perphenazine |
| BenztropineAlso: CogentinDaily tablets of 1 to 2 mg | Drug | Aripiprazole, Olanzapine, Perphenazine |
Primary outcome
Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study
Time frame: Baseline
Goal was to randomize 60 participants who met eligibility criteria.
1 secondary outcome
Antipsychotic Efficacy, Defined as Completion of the Trial Without Psychiatric Hospitalization, Clinician Decision to Discontinue Treatment, or Patient Decision to Discontinue Treatment
Time frame: Measured over 28 weeks of study visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marvin Swartz, MD principal investigator
Duke University
T. Scott Stroup, MD, MPH principal investigator
University of North Carolina, Chapel Hill
Joseph P. McEvoy, MD principal investigator
Duke University
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Olanzapine, Perphenazine and Aripiprazole in people with Schizophrenia, run by National Institute of Mental Health (NIMH) at 13 sites 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 5 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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 8 Feb 2013). 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?
Feasibility of Randomizing a Cohort of Participants Meeting the Inclusion and Exclusion Criteria of the Study (time frame: Baseline). 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 8 Feb 2013.