Atomoxetine Asian Study in Adult Subjects With Attention-Deficit/Hyperactivity Disorder (ADHD)

Browse trials for

• Hyperkinesis 729
• Attention Deficit Disorder with Hyperactivity 1,514

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 45 is below the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Study arms

• Experimental
  Atomoxetine

  Drug: Atomoxetine

Interventions

• DrugAtomoxetine

  Study drug is administered once daily in the morning. This study is designed with 4-step titration. At Day 1, study drug is started from 40 mg/day, and is increased to 80 mg/day on Day 7, 105 mg/day on Day 14, and 120 mg/day on Day 28. Total administration period is 8 weeks. The dosage is adjusted according to investigator's decision based on safety and tolerability.

  Also known as: LY139603, Strattera

Primary outcomes

1. Discontinuations Due to Adverse Events (AE)

   The definition of a study adverse event was any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.

   Time frame: Baseline to 8 Weeks

Secondary outcomes

1. Change From Baseline to 8 Week Endpoint in Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rated:Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score

   Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Investigator Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.

   Time frame: Baseline and 8 Weeks

2. Change From Baseline to 8 Week Endpoint in Clinical Global Impressions-ADHD Severity (CGI-ADHD-S)

   Measures severity of the patient's overall severity of ADHD symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).

   Time frame: Baseline and 8 Weeks

3. Change From Baseline to 8 Week Endpoint in Conners' Adult ADHD Rating Scale-Self Rated:Screening Version (CAARS-S:SV) Total ADHD Symptom Score

   Conners' Adult Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale-Self Rating:Screening Version. Total ADHD symptom score consisted of 18 items (sum of inattention and hyperactivity-impulsivity subscales) using a 4-point scale (0=not at all/never to 3=very much/very frequently) for total score range of 0 to 54.

   Time frame: Baseline and 8 Weeks

4. Change From Baseline to 8 Week Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17)

   The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).

   Time frame: Baseline and 8 Weeks

5. Change From Baseline to 8 Week Endpoint in Hamilton Anxiety Rating Scale (HAMA-14)

   The HAMA-14 scale measures anxiety symptoms accompanying Major Depressive Disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56.

   Time frame: Baseline and 8 Weeks

6. Change From Baseline to 8 Week Endpoint in Stroop Color Word Test

   This was a psychological test to observe the interference in which disparity between the meaning and color affects reading speed. A subject was given 3 tasks of recognition: reading the printed colored ink (Color Test), reading color words in black ink (Word Test), and interference, reading color words printed in different colored ink (Word-Color Test). The test was scored on the number of correct answers. There were 100 items for each of the three categories and if they made it through the 100 words with time remaining, they would repeat the list.

   Time frame: Baseline and 8 Weeks

7. Change From Baseline to 8 Week Endpoint in Short Form-36 Version 2 (SF-36v2)

   SF-36 assesses quality of life (QoL) on 8 domains and 2 summary scores (mental component summary \[MCS\] and physical component summary \[PCS\]). MCS and PCS scores=0-100 (higher scores indicate better QoL). Raw domain scores: general health=5-25; physical functioning=10-30; role-physical=4-20; role-emotional=3-15; social functioning=2-10; bodily pain=2-12; vitality=4-20; mental health=5-25. Using norm based scores, all domains, MCS and PCS scores have average score of 50 with standard deviation of 10. Norm-based score=Z-score\*10+50 in each subscale. Range cannot be specified in norm-based scores.

   Time frame: Baseline and 8 Weeks

8. Number of Participants With Potentially Clinically Significant Changes in Vital Signs During the Study

   Vital signs reported are Pulse (beats per minute \[bpm\]), Systolic Blood Pressure (SBP) (mmHg), and Diastolic Blood Pressure (DBP) (mmHg).

   Time frame: Baseline to 8 Weeks

9. Significant Changes in Body Weight During the Study

   Potentially clinically significant weight loss was defined as any decrease of at least 7 percent (%). Potentially clinically significant weight gain was defined as any increase of at least 7%.

   Time frame: Baseline to 8 Weeks

10. Number of Participants With Abnormal QTc Interval Based on International Conference on Harmonisation Criterion

    The Fridericia correction of the QT interval (QTcF) was used.

    Time frame: Baseline to 8 Weeks

11. Cytochrome P450 2D6 (CYP2D6) Phenotype Status

    CYP2D6 is the primary atomoxetine metabolizing enzyme. Metabolizzer status was determined by focusing on the normal, decreased, and defective allele. Poor metabolizer = defective/defective. Extensive metabolizer is all except for poor metabolizer.

    Time frame: 8 Weeks

Baseline characteristics