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 Stimulation

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 Stimulation - cross-over and open label study to evaluate PD activity of TAK-653

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47989

Enrollment

Registered

2018-12-11

Start date

2019-01-21

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression depressive disorder

Interventions

Test: TAK-653 0.5 mg TAK-653 6 mg Matching placebo Open label periode: Ketamine 0.5 mg/kg

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
The change of peak-to-peak amplitude of the MEP obtained with single-pulse TMS (stimulation intensity: 120% of baseline rMT) at 2* hours after administration of TAK-653 from pre-dosing baseline, compared to placebo. The change of rMT obtained with single-pulse TMS at 2* hours after administration of TAK-653 from pre dosing baseline, compared to placebo.	—

Secondary

Measure	Time frame
- Magnitude of long intracortical inhibition (LICI) obtained with paired-pulse TMS (stimulation intensity conditioning pulse and test pulse: 120% of baseline rMT). - Magnitude of Short intracortical inhibition (SICI) obtained with paired-pulse TMS (stimulation intensity: conditioning pulse 80% of baseline rMT; test pulse: 120% of baseline rMT). - The resting motor threshold (rMT) obtained with single-pulse TMS assessing ketamine effects, as well as at 24 hours.. - The peak-to-peak amplitude of the MEP obtained with single-pulse TMS (stimulation intensity: 120% of baseline rMT) assessing ketamine effects, as well as at 24 hours.	—

Measure

Time frame

- Magnitude of long intracortical inhibition (LICI) obtained with paired-pulse TMS (stimulation intensity conditioning pulse and test pulse: 120% of baseline rMT). - Magnitude of Short intracortical inhibition (SICI) obtained with paired-pulse TMS (stimulation intensity: conditioning pulse 80% of baseline rMT; test pulse: 120% of baseline rMT). - The resting motor threshold (rMT) obtained with single-pulse TMS assessing ketamine effects, as well as at 24 hours.. - The peak-to-peak amplitude of the MEP obtained with single-pulse TMS (stimulation intensity: 120% of baseline rMT) assessing ketamine effects, as well as at 24 hours.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)