What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Active HD-tDCS, Antipsychotics, mood stabilizers, etc., or Sham HD-tDCS. The registry lists allocation as randomized. This randomly assigned, neither you nor the study doctors know who gets the real treatment, sham-controlled clinical trial aims to measure the how well it works and underlying biological mechanisms of HD-tDCS targeting the primary somatosensory cortex in adolescents with bipolar depression.
They plan to enroll about 100 people at Nanjing. Taking part typically means taking a study drug (or dummy pill), using or being fitted with a device plus check-ins.
Official title (unrewritten)
High-Definition Transcranial Direct Current Stimulation (HD-tDCS) Targeting the Primary Somatosensory Cortex for Bipolar Depression in Adolescents: A Randomized Double-Blind Controlled Trial
Interventions: Active HD-tDCS, Antipsychotics, mood stabilizers, etc., Sham HD-tDCS
Primary outcome (registry wording): Change from baseline in depressive symptoms assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at Week 2.