American Psychiatric Association

March 16, 2018 | Editorial Board | View Online | Psychiatric News

In This Issue



Industry brief: FDA Approves Latuda for Bipolar Depression in Children and Adolescents

The Food and Drug Administration (FDA) has approved Sunovion Pharmaceuticals’ Latuda (lurasidone HCl) for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in youth aged 10 to 17.

According to a press release from Sunovion, the approval for this expanded pediatric indication was based on data from a six-week, phase 3 clinical study of 347 children and adolescents with bipolar depression. After six weeks, the participants who received once-daily Latuda (20 to 80 mg/day) showed statistically significant improvements in depression symptoms compared with those taking placebo—as indicated by change from baseline on Children’s Depression Rating Scale, Revised (CDRS-R) total scores and Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S) depression score.

The medication was generally well-tolerated, with nausea, weight gain, and insomnia being the most common adverse effects.

Latuda is already approved as a monotherapy or adjunctive therapy with lithium or valproate for the treatment of adults with bipolar depression. The medication is also approved for the treatment of adults and adolescents (aged 13 to 17) with schizophrenia.

Industry brief: Novartis and Pear Team Up to Develop New Digital Therapies

Pear Therapeutics in March announced that the company has entered into a collaboration with Novartis to develop prescription digital therapeutics for schizophrenia and multiple sclerosis (MS). The collaboration brings together Novartis’ expertise in the clinical drug development and commercialization with Pear’s experience with digital therapeutics design and implementation. (In September 2017, Pear Therapeutics obtained the first-ever FDA clearance for a digital program to aid in the treatment of substance use disorders. The program is called reSET.)

Novartis will leverage their experience to help shuttle Pear’s Thrive—a smartphone and web-based application that was developed to help patients with schizophrenia manage their symptoms and adhere to their antipsychotic regimen—through the clinical pipeline. In turn, Pear will help develop a new therapeutic application that targets mental health symptoms such as depression and anxiety in patients with MS.



A 37-year-old woman with schizophrenia is brought to the clinic by her mother. She has a history of five hospitalizations in the last 7 years for severe psychotic symptoms in the setting of nonadherence to oral medications. You consider using risperidone long-acting injectable (LAI) and propose a treatment plan to the team. The patient has not used risperidone in the past. What is your plan for initiation of this medication?

A. Initial injection of risperidone LAI 25 mg intramuscularly today without oral medication.

B. Initial treatment with risperidone oral for two weeks and then switch to LAI.

C. Initial treatment with risperidone oral until tolerability is established and continued for three weeks after LAI is administered.

D. Initial treatment with risperidone oral and LAI today for two weeks, then LAI monotherapy.

E. Initial treatment with risperidone LAI today with plan to titrate LAI dose weekly to desired efficacy.

Click Here to Answer


Cannabidiol, an Adjunct Player in the Antipsychosis Arsenal

Read more

Psychotropic Polypharmacy Among Youths With Serious Emotional and Behavioral Disorders Receiving Coordinated Care Services

Read more