Study Phase 3

A Double-blind, Placebo-controlled, Randomized Trial to Evaluate the Safety, Tolerability and Efficacy of CONCERTA® (Methylphenidate Hydrochloride) Augmentation of SSRI/SNRI Monotherapy in Adult Patients With Major Depressive Disorder.

Trial Information

Generic NameMethylphenidate HClProduct NameCONCERTA®Therapeutic AreaNervous SystemProduct ClassPsychoanalepticsPharmacological SubgroupPsychostimulants, Agents Used for ADHD and NootropicsChemical SubgroupCentrally Acting SympathomimeticsCondition StudiedDepressive Disorder, Major
Sponsor Protocol Number42603MDD3001 (CON-CAN-3)Enrollment145Data PartnerJohnson & Johnson% Female64.8%Mean/Median Age (Years)43.8% White97.9%

Supporting Documentation

  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.