A Randomized, Double-blind, Placebo-Controlled, 3-Period Crossover Study Followed by 1 Open-label Comparator Period to Evaluate Central Pharmacodynamic Activity of TAK-653 in Healthy Volunteers Using Transcranial Magnetic Stimulatio
- Conditions
- Depressiondepressive disorder10027946
- Registration Number
- NL-OMON47989
- Lead Sponsor
- Millenium Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
1. Understand the study procedures and agree to participate by providing written informed consent.
2. Be willing and able to comply with all study procedures and restrictions.
3. Be male or female (of nonchildbearing potential) aged 18 to 55 years, inclusive, at the Screening Visit.
4. Have a body mass index >=18.5 and <=30.0 kg/m2 at the Screening Visit.
5. Be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead ECG, and vital sign measurements performed at the screening visit and before the first dose of study drug.
6. Meet the birth control requirements outlined in the protocol.
1. Has a positive alcohol or drug screen.
2. Has a positive pregnancy test.
3. Is a lactating/nursing woman.
4. Has a clinically significant previous or current psychiatric disorder according to the (DSM5) Diagnostic and Statistical Manual of Mental Disorders, including substance use disorder.
5. Has a history of intracranial mass lesion, hydrocephalus and/or head injury or trauma.
6. Has metal objects in brain or skull
7. Has a cochlear implant or deep brain stimulation device.
8. Has a history of epilepsy, seizures, or convulsions.
9. Has a family history of epilepsy, seizures, or convulsions.
10. Has abnormal sleeping patterns (eg, working night shifts)
11. Has a resting motor threshold (rMT) of more than 83% of the maximum stimulator output, measured using TMS-electromyogram (EMG) during screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The change of peak-to-peak amplitude of the MEP obtained with single-pulse TMS<br /><br>(stimulation intensity: 120% of baseline rMT) at 2* hours after administration<br /><br>of TAK-653 from pre-dosing baseline, compared to placebo.<br /><br>The change of rMT obtained with single-pulse TMS at 2* hours after<br /><br>administration of TAK-653 from pre dosing baseline, compared to placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Magnitude of long intracortical inhibition (LICI) obtained with paired-pulse<br /><br>TMS (stimulation intensity conditioning pulse and test pulse: 120% of baseline<br /><br>rMT).<br /><br>- Magnitude of Short intracortical inhibition (SICI) obtained with paired-pulse<br /><br>TMS (stimulation intensity: conditioning pulse 80% of baseline rMT; test pulse:<br /><br>120% of baseline rMT).<br /><br>- The resting motor threshold (rMT) obtained with single-pulse TMS assessing<br /><br>ketamine effects, as well as at 24 hours..<br /><br>- The peak-to-peak amplitude of the MEP obtained with single-pulse TMS<br /><br>(stimulation intensity: 120% of baseline rMT) assessing ketamine effects, as<br /><br>well as at 24 hours.</p><br>