Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03323437|
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : August 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Spectrum and Other Psychotic Disorders||Drug: Risperidone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Biomarkers of Conversion Risk and Treatment Response in Early-Stage Schizophrenia|
|Actual Study Start Date :||September 15, 2017|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||October 2022|
Medication-free individuals during first-episode of psychosis who will receive 4 weeks of treatment with risperidone
Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again.
No Intervention: Control
Healthy, psychosis-free controls who will not receive risperidone
- Change in biomarkers of treatment response: Dorsal Caudate (DCA) GABA levels [ Time Frame: Baseline and 4 weeks of treatment ]Dorsal Caudate (DCA) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response.
- Change in biomarkers of treatment response: Dorsal Caudate (DCA) Glutamate [ Time Frame: Baseline and 4th week of treatment ]Dorsal Caudate (DCA) Glutamate levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response.
- Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) GABA [ Time Frame: Baseline and 4th week of treatment ]Medial Prefrontal Cortex (MPFC) GABA levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response.
- Change in biomarkers reflecting treatment response: Medial Prefrontal Cortex (MPFC) Glutamate [ Time Frame: Baseline and 4th week of treatment ]Medial Prefrontal Cortex (MPFC) Glutamate levels will be ascertained at baseline and after 4 weeks of treatment using MRI scan with 1H MRS to assess treatment response.
- Changes in neurocognitive performance: MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline and 4th week of of treatment ]Memory, attention, reasoning, emotional intelligence, and verbal ability will be assessed using the MCCB before and after 4 weeks of treatment.
- Changes in everyday functioning: University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA) [ Time Frame: Baseline and 4th week of treatment ]Ability to function in a variety of everyday tasks from six domains (Financial Skills, Communication, Comprehension/Planning, Transportation, Household Management and Medication Management) will be assessed using the University of California San Diego Performance-based Skills Assessment (UPSA) before and after 4 weeks of treatment.
- Changes in clinical symptomatology: Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Treatment week 1, treatment week 2, treatment week 3 ]
Changes in Positive and Negative Symptoms will be assessed across the treatment period using the PANSS.
Participants are rated on a scale of
- (Moderate severe)
to describe Positive, Negative and General symptomatology. Items from each subscale (Positive, Negative, and General) are summed for their respective scales, with lower numbers indicating less severe or absent symptomatology, and higher scores indicating more severe symptoms. A total sum of all subscales is also computed to reflect overall symptom severity.
Positive Subscale: 7 items, minimum score = 7, maximum score = 49 Negative Subscale: 7 items, minimum score = 7, maximum score = 49 General Subscale: '16 items, minimum score = 16, maximum score = 112 Total Score: 30 items, minimum score = 30, maximum score = 210.
- Changes in motor symptomatology: Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Treatment week 1, treatment week 2, treatment week 3 ]
Changes in motor symptomatology associated with tardive dyskinesia (TD) assessed using the Abnormal Involuntary Movement Scale (AIMS).
The measure consists of 14 items with scale 0 None
- Severe Higher ratings -> higher levels of motor symptoms. Items 1-7 assess abnormal movements for parts of the body. Ratings are summed to produce a score of total motor symptomatology (min 0, max 28).
Item 8 = rating of overall symptom severity based on observation, using the same scale as above.
Item 9 = rating of the incapacity of the subject due to abnormal movements, using the same scale as above.
Item 10 = rating of the level of awareness and distress in the participant over the abnormal movements, with 0 =No Awareness
- = Aware, no distress
- = ~, mild ~
- = ~, moderate ~
- = ~, severe ~ Item 11-13 = yes/no, rule out dental problems that can lead to a mistaken diagnosis of TD.
Item 14 = yes/no if symptoms disappear or persist during sleep.
- Changes in clinical severity: Clinical Global Impression Scale [ Time Frame: treatment week 1, treatment week 2, treatment week 3 ]
Changes in clinical severity over the course of treatment will be monitored using the The Clinical Global Impression Scale (CGI) consists of two items.- Severity scale (CGI-S).
Severity - The first item assesses the patient's current level of mental health symptomatology compared to the clinician's experience with other patients with the same diagnosis. The scale ranges from
- (Normal, not at all ill)
- (Borderline mentally ill)
- (Mildly ill)
- (Moderately ill)
- (Markedly ill)
- (Severely ill)
- (Among the most extremely ill patients)
Improvement - The second item assesses how much the patient's symptomatology has changed since the last clinical visit.
- Very much improved
- Much improved
- Minimally improved
- No change
- Minimally worse
- Much worse
- Very much worse
- Changes in global functioning: Global Assessment of Functioning (GAF) [ Time Frame: Treatment week 1, treatment week 2, treatment week 3 ]
Changes in global functioning over the course of treatment will be assessed using the Global Assessment of Functioning (GAF).
Participants are rated 1-100 on their level of functioning, according to clinical observation:
91 - 100 No symptoms. 81 - 90 Absent or minimal symptoms 71 - 80 If symptoms are present, they expected reactions to stressors 61 - 70 Some mild symptoms 51 - 60 Moderate symptoms 41 - 50 Serious symptoms 31 - 40 Impairment in reality testing or communication or major impairment in several areas 21-30 Behavior influenced by delusions or hallucinations or serious impairment in communication/judgment/inability to function in almost all areas 11-20 Some danger of hurting self or others or occasionally fails to maintain minimal personal hygiene or gross impairment in communication 1-10 Persistent violence risk or lack of self-care 0 No info
- Recreational Substances Used by Patients as Recorded by the Substance Use Questionnaire [ Time Frame: This measure is administered on Day 1 of the study. ]This measure is a self-reported questionnaire which assesses for any use of the following substances within the past month prior to the initial research visit Tobacco (if the respondent indicates that they have used tobacco in the past month, they are additionally asked, "On average, how many cigarettes per day have you smoked in the past 7 days?" Alcohol, Cocaine, Marijuana, Opiates, Amphetamines, PCP Other Drugs of Abuse (if the respondent indicates they have used other drugs of abuse within the past month of the initial research visit, they are given the opportunity to "specify" which other drugs of abuse they used
- Participants' Verbal I.Q as Assessed by the WTAR to Determine Clinical Eligibility [ Time Frame: This measure is completed on Day 1 of the study. ]This measure assesses a participant's verbal ability to determine whether they are cognitively able to complete the measures involved in the study. The participant will read from a list of 50 English words and the rater will record whether the pronunciation was correct on a score card for each word spoken. A standard score below the 70th percentile on this measure is indicative of an intellectual disability which would exclude a participant from being clinically and cognitively eligible to complete this study.
- Participants' Self-Reported Handedness as Recorded by the Edinburgh Handedness Scale [ Time Frame: This measure is completed on Day 1 of the study. ]This measure assesses a participant's preference regarding which hand they would use to complete a specific task. They have the option to indicate whether they would use they would always or most of the time use their left, right, or both left and right hands to complete each task. This measure assesses handedness based on the amount of responses which indicate the participant is either left handed, right handed, or ambidextrous.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323437
|Contact: Lawrence Kegeles, MD, Ph.D.||email@example.com|
|Contact: Ragy Girgis, MDfirstname.lastname@example.org|
|United States, New York|
|New York State Psychiatric Institute & Columbia University||Recruiting|
|New York, New York, United States, 10032|
|Contact: Lawrence Kegeles, M.D., Ph.D. 646-774-5560 email@example.com|
|Contact: Ragy Girgis, M.D. 646-774-5553 firstname.lastname@example.org|
|Principal Investigator: Lawrence Kegeles, MD, PhD|
|Principal Investigator: Ragy Girgis, MD|
|Sub-Investigator: Roberto Lewis, MD|
|Principal Investigator:||Dikoma C. Shungu, Ph.D.||Weill Cornell Medicine|