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Following Yale University resuming in-person research activities, the investigators no longer had dedicated funding for the study and were unable to secure additional funding to meet the research goals.
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The purpose of this study is to assess vitamin D as a therapeutic adjunct in the stimulant treatment of ADHD.
The specific aim of this study is to determine whether acute calcitriol (vitaminD) administration (compared to placebo) enhances the neurocognitive effects of of current stimulant medications as measured by tasks of vigilance/attention, spatial working memory, and reversal learning in individuals with (attention deficit hyperactivity disorder (ADHD) using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
Primary Hypothesis: It is hypothesized that calcitriol (versus placebo) administration will enhance positive neurocognitive effects of current stimulant medications in individuals with ADHD.
Secondary (Exploratory) Hypothesis: It is hypothesized that calcitriol (versus placebo) administration alone will also enhance neurocognitive performance on tasks of attention/vigilance and/or spatial working memory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calcitriol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcitriol | Drug | A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design. |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced positive neurocognitive effects on the CPT-IP | On the Continuous Performance Task (CPT-IP) subjects are shown a random sequence of different numbers and are instructed to press a button as quickly and accurately as possible upon detection of two identical pairs of numbers, and to withhold their response to any other sequence of letters. Outcomes will be measured by d prime. | Up to 5 hours |
| Enhanced positive neurocognitive effects on the Spatial working memory task | The spatial working memory task is a measure of working memory. As part of the task, stimuli will be projected onto the computer screen and target stimuli can be spatial locations, different visual stimuli, sound or text. Outcomes will be measured by percent correct. | Up to 5 hours |
| Enhanced positive neurocognitive effects on the PRLT | The Probabilistic Reversal Learning Task (PRLT) measures subjects' perseverative responding in the context of changing reward contingencies / cues. Outcomes will be measured by numbers of reversal achieved, total points, and error types. | Up to 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Enhanced positive neurocognitive effects on the CPT-IP- hits | Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors. | Up to 5 hours |
| Enhanced positive neurocognitive effects on the CPT-IP- false alarms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Potenza, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMHC | New Haven | Connecticut | 06519 | United States |
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| Placebo | Other | A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design. |
|
Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors. |
| Up to 5 hours |
| Enhanced positive neurocognitive effects on the CPT-IP- random errors | Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors.Enhanced positive neurocognitive effects on the CPT-IP will be measured by counts of hits, false alarms, and random errors. | Up to 5 hours |
| Spatial working memory task- reaction time | Enhanced positive neurocognitive effects be measured by reaction time on the spatial working memory task. | Up to 5 hours |
| Enhanced positive neurocognitive effects on the PRLT - win-switch / lose-stay rate | Enhanced positive neurocognitive effects on the PRLT will be measured by win-switch / lose-stay rate. | Up to 5 hours |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002117 | Calcitriol |
| ID | Term |
|---|---|
| D004100 | Dihydroxycholecalciferols |
| D006887 | Hydroxycholecalciferols |
| D002762 | Cholecalciferol |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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