Vanilla Study
Sprites Study

Palatin BMT-302
A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial with an open-label extension phase to evaluate efficacy and safety of subcutaneously administered bremelanotide in premenopausal women with Hypoactive Sexual Desire Disorder (HSDD) (with or without Decreased Arousal)

CYT300-01
Phase I/II safety and efficacy study to evaluate Autologous Protease Inhibitor Concentrate-Cell Free (APIC-CF) therapy for mild to moderate knee osteoarthritis

“ASPIRE EU” (Aripiprazole Intramuscular Depot Program in Schizophrenia)
A 38 week, Multicenter, Randomized, Double-blind, Active-controlled study to evaluate the efficacy, safety, and tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC 14597) as Maintenance Treatment in Patients with Schizophrenia

MEM-MD-91
An Open-label study of the safety and tolerability of Memantine in pediatric patients with Autism, Asperger’s disorder, or Pervasive developmental disorder not otherwise specified (PDD-NOS)

MEM-MD-69
An Open-label, extension study of the safety and tolerability of Memantine in pediatric patients with Autism, Asperger’s disorder, or pervasive developmental disorder not otherwise specified (PDD-NOS)

MEM-MD-68
A Double-blind, placebo-controlled, randomized withdrawal study of the safety and efficacy of Memantine in pediatric patients with Autism, Asperger’s disorder, or pervasive developmental disorder (PDD-NOS) previously treated with Memantine.

Pfizer B2061014
A multicenter, randomized, double-blind, placebo-controlled, fluoxetine-reference, parallel group study to evaluate the efficacy, safety and tolerability of Desvenlafaxine succinate sustained release (DVS SR) in the treatment of children and adolescent outpatients with major depressive disorder.

Sunovion D1050325
A 6-week randomized, parallel, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of Lurasidone in children and adolescent subjects with irritability associated with autistic disorder.

Sunovion D1050302
A104-week, flexible-dose, open-label, multicenter, extension study to evaluate the long-term safety and effectiveness of Lurasidone in pediatric subjects with schizophrenia and subjects with irritability associated with autistic disorder.

Shire SPD489-405
A phase 4, randomized, double-blind, multicenter, parallel-group, active-controlled, dose-optimization safety and efficacy study of SPD489-405 (Vyvanse©) compared with OROS-MPH (Concerta©) with a placebo reference arm, in adolescents aged 13-17 years with attention-deficit/hyperactivity disorder (ADHD)

“SPRITES” ( Sertraline Pediatric Registry for the Evaluation of Safety)
A non-interventional, longitudinal, cohort study to evaluate the effects of long-term Sertraline treatment in children and adolescents.

VLZ-MD-21
A double-blind, placebo-controlled, evaluation of the safety and efficacy of Vilazodone in adolescent patients with major depressive disorder.

Roche BP28420 “Vanilla”
(Vasopressin Antagonist to Improve Social Communication in Autism)

A multicenter, randomized, double-blind, 12-week , parallel group, placebo-controlled proof of concept study to investigate the efficacy and safety of RO528119 in individuals with autism spectrum disorders (ASD)

Definitions

Some common research term definitions:

Placebo-controlled: A term used to describe a method of research in which an inactive substance (a placebo) is given to one group of participants, while the treatment (usually a drug or vaccine) being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective than the placebo.

Double-blind: Term used to described a study in which both the investigator or the participant are blind to (unaware of) the nature of the treatment the participant is receiving. Double-blind trials are thought to produce objective results, since the expectations of the researcher and the participant about the experimental treatment such as a drug do not affect the outcome.

Open –label: A term used to describe the situation when both the researcher and the participant in a research study know the treatment the participant is receiving. Open-label is the opposite of double-blind when neither the researcher nor the participant knows what treatment the participant is receiving.

Randomized: The use of chance alone to assign the participants in an experiment or trial to different groups in order to fairly compare the outcomes with different treatments.