Phase 2
Completed N=12
PET Study Examining the Dopaminergic Activity of Armodafinil in Adults
Healthy
Source: ClinicalTrials.gov NCT00592943 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcomePrimary: Armodafinil DAT Occupancy in Caudate — 34.0; 60.5; 40.4; 65.2 μg/mL
Summary
The specific aims of this study are 1) to document the Dopamine Transporter (DAT) receptor occupancy of armodafinil using positron emission tomography (PET) scanning with C-11 altropane as the ligand and 2) to document the increased intrasynaptic dopamine produced by armodafinil using PET scanning with C-11 raclopride as the ligand. We hypothesize that DAT occupancy will be low with armodafinil; less than the DAT occupancy produced by therapeutic doses of methylphenidate. We also hypothesize that increases in intrasynaptic dopamine will be relatively low with armodafinil.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Armodafinil DAT Occupancy in Caudate |
34.0; 60.5; 40.4; 65.2 | — |
| PRIMARY Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (With Outlier) |
17.8; 7.0 | — |
| PRIMARY Armodafinil Extracellular Dopamine in Caudate at 2.5 Hours (Without Outlier) |
6.0; 5.3 | — |
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent to participate in the study.
- Age: 18 - 35
- If female, non-pregnant, non-nursing with a negative serum pregnancy test and using an adequate form of birth control.
- Supine and standing blood pressure within the range 110/60 to 150/95 mmHg.
- Heart rate, after resting for 5 minutes, within the range 46-90 beats/min.
- Right-handed.
Exclusion Criteria
- Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism.
Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator.
- Scores of Baseline Scales:
Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)(Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)(Beck, Ward et al. 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
- Tics or Tourette's Syndrome.
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
- Any clinically significant chronic medical condition, in the judgment of the investigator.
- Mental impairment as evidenced by an I.Q. <75.
- Exposure to dopamine receptor antagonists within the previous three (3) months.
- Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
- Subjects receiving psychotropic medication.
- Any clinically significant abnormality in the screening laboratory tests, vital signs, or 11-lead ECG, outside of normal limits.
- Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
Data sourced from ClinicalTrials.gov (NCT00592943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.