An Exploratory Trial of AZD3480 (TC-1734) for the Treatment of Adult Attention-Deficit/Hyperactivity Disorder (ADHD)
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, ADHD |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | May 2008 |
| End Date: | July 2009 |
A 3-way cross-over trial of two weeks of treatment with three drug conditions. AZD3480 will
be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with
DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping
will be completed at screening and slow metabolisers will be excluded from participation in
this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made
during each treatment period. Safety and tolerability assessments will be a major component
of the trial and all serious adverse events (SAE) will be immediately (within 24 hours)
reported to both Targacept and to AstraZenca.
be given in doses of (A) 5mg/day, (B) 50 mg/day and (C) placebo to 24 non-smoking adults with
DSM-IV confirmed ADHD. Three week washout between each treatment period. CYP2D6 genotyping
will be completed at screening and slow metabolisers will be excluded from participation in
this study. Cognitive, ADHD symptom, safety and pharmacokinetic (PK) assessments will be made
during each treatment period. Safety and tolerability assessments will be a major component
of the trial and all serious adverse events (SAE) will be immediately (within 24 hours)
reported to both Targacept and to AstraZenca.
Inclusion Criteria:
- Confirmed diagnosis of DSM-IV ADHD
- Score of equal or more than 2 on at least six of nine items in at least one of the
subscales of the Connor´s Adult ADHD Rating Scale (CAARS-INV)
- Score of equal or more than 4 (at least moderate severity) on the Clinical Global
Impressions-Severity (CGI-S) test
Exclusion Criteria:
- Current DSM-IV Axis I psychiatric disorder (other than ADHD)
- Current user of cigarettes or other nicotine-containing product.
- Slow metabolizers as indicated by CYP2D6 genotyping.
- Use of drugs affecting cognitive function within 8 weeks prior to enrollment visit or
intended use during the study.
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