Study to Evaluate the Safety and Efficacy of PEER Interactive to Inform Medication Prescription for Subjects With a Primary Diagnosis of Depression
Status: | Suspended |
---|---|
Conditions: | Depression, Depression |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 65 |
Updated: | 2/2/2019 |
Start Date: | November 2016 |
End Date: | March 2020 |
A Prospective, Double Blind, Randomized, Controlled, Multisite Study to Evaluate the Utility, Safety, and Efficacy of Using PEER Interactive to Inform Medication Prescription to Subjects With a Primary Diagnosis of a Depressive Disorder(SMART-MD)
This is a prospective, multicenter, randomized, double-blind, controlled study to evaluate
the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform
medication prescription in subjects with a primary diagnosis of depression with comorbidity
of non-psychotic behavioral disorders versus treatment as usual, as determined by the
investigator. The primary measurement for improvement of the subjects depression will be a
self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report
16 , but the investigators will also collect information on their clinical global improvement
and any reduction in adverse events.
the effectiveness of Psychiatric Electroencephalogram Registry (PEER) Interactive to inform
medication prescription in subjects with a primary diagnosis of depression with comorbidity
of non-psychotic behavioral disorders versus treatment as usual, as determined by the
investigator. The primary measurement for improvement of the subjects depression will be a
self-evaluation questionnaire, the Quick Inventory of Depressive Symptomatology-Self Report
16 , but the investigators will also collect information on their clinical global improvement
and any reduction in adverse events.
This study is prospective in nature. Subjects in the control group will be treated according
to treatment as usual and best judgment of the treating physician. For the experimental group
the treating physician will follow the guidance of the subject's PEER Interactive Report as
regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an
electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The
wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 3 months after the initial treatment. The patient will be
seen on a routine basis and assessments will be made at each interaction to evaluate the
patient's improvement in mental health. The subjects will also be closely evaluated to
determine if they are experiencing any psychiatric specific adverse events. The investigator
is allowed to treat the patient according to their best medical judgment, which may include
adding or changing medications, seeing the patient more frequently, or other interventions
such as the use of sleep aids.
to treatment as usual and best judgment of the treating physician. For the experimental group
the treating physician will follow the guidance of the subject's PEER Interactive Report as
regards sensitivity to on-label medications and classes of medication.
The subjects will be washed out of all current medications prior to having an
electroencephalogram (EEG), which is necessary to generate the PEER Interactive Report. The
wash out period for outpatients is no longer than 14 days.
The subjects will be followed for 3 months after the initial treatment. The patient will be
seen on a routine basis and assessments will be made at each interaction to evaluate the
patient's improvement in mental health. The subjects will also be closely evaluated to
determine if they are experiencing any psychiatric specific adverse events. The investigator
is allowed to treat the patient according to their best medical judgment, which may include
adding or changing medications, seeing the patient more frequently, or other interventions
such as the use of sleep aids.
Inclusion Criteria:
1. Male and female subjects between the ages of 18 - 65 years of age or older who speak
and read English.
2. Subjects able to provide written informed consent to participate in the study.
3. Subjects with a primary diagnosis of a Diagnostic and Statistical Manual of Mental
Disorders (DSM-V) depressive disorder. Please see Appendix D for definitions.
4. Subjects with comorbidity of a non-psychotic behavioral disorder. Please see Appendix
D for definitions.
5. Subjects with comorbidity of mild traumatic brain injury (mTBI) are eligible for
inclusion in this study.
6. Subjects with comorbidity of post-traumatic stress disorder (PTSD) are eligible for
inclusion in this study. A score of 45 or greater on the PTSD Checklist Civilian
(PCL-C) measurement tool will qualify a subject for inclusion of diagnosis of PTSD as
a comorbid condition.
7. Able to stop specified medications, including drugs of abuse, for 5 half-lives of the
medication(s). See Appendix E for a list of the withdrawal periods for medications.
The potential subject's primary care physician may be consulted to make these
determinations.
8. Able to be washed out of medications within 14 days, i.e. 5 half-lives are not longer
than 14 days (See Appendix E).
9. Ability to comply with the requirements of the study.
Exclusion Criteria:
1. Male and female subjects less than 18 years old or greater than 65 years old.
2. Subjects who cannot provide written informed consent.
3. Diagnosis of a psychotic disorder. Please see Appendix D for definitions.
4. History of, or current, open head brain trauma.
5. Subjects with comorbidity of traumatic brain injury (TBI) who experienced greater than
30 minutes loss of consciousness, greater than 24 hour alteration in consciousness or
mental status, greater than 24 hours of post traumatic amnesia, or a Glasgow Coma
Scale (best available score in first 24 hours) of less than 13.
6. Subjects who, in the opinion of the investigator would not be good candidates to be
washed out of specified medications (Appendix E) and are unable to washout medications
and/or supplements in a period of 14 days or less.
7. History of: craniotomy, cerebral metastases, cerebrovascular accident; current
diagnosis of seizure disorder, schizophrenia, schizo-affective disorder, dementia,
mental retardation, or major depression with psychotic features; or use of depot
neuroleptics in last 12 months.
8. Clinically significant medical illness, including thyroid disorders, diabetes, etc.,
which cannot be remediated with medication, e.g. synthroid, insulin, etc.
9. Participation in any other therapeutic drug study within 60 days preceding inclusion.
10. Known pregnancy and/or lactation, or intent to become pregnant during this study.
11. Chronic or acute pain requiring prescription pain medication(s) (narcotic or synthetic
narcotic).
12. Candidates with any metal, shrapnel or other similar objects in the head that could
affect the QEEG.
13. Candidates currently stable on current medications.
14. Pre-entry subject whose urine drug screen is positive for drugs of abuse.
We found this trial at
1
site
1033 Dresser Court
Raleigh, North Carolina 27609
Raleigh, North Carolina 27609
Principal Investigator: Sandeep Vaishnavi, M.D.
Phone: 919-792-3940
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