Professional Resource: Adult Trials

FLCR adult trial information for health professionals

Following is summary information on our currently-enrolling adult trials, along with links to detailed NIH (clinicaltrials.gov) information and information for patients, where available. Please contact Dr. Atkinson at 585.241.9670 or sda@flclinical.com if you have a patient who might be a candidate for one of these studies.

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Bipolar Depression (Allergan)

Protocol(s): RGH-MD-53

Age range: 18-65

Study summary: This study investigates the efficacy of a fixed-dose regimen of cariprazine 1.5 mg/day or 3 mg/day compared to placebo for treatment of the depressive episode in patients with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

Bipolar Depression (Intracellular)

Protocol(s): ITI-007-401, ITI-007-402

Age range: 18-65

Study summary: ITI-007-401 will evaluate the efficacy and safety of ITI-007 in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

ITI-007-402 will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Depression, Treatment-Resistant (Axsome)

Protocol(s): AXS-05-301

Age range: 18-65

Study summary: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Major Depressive Disorder (Allergan)

Protocol(s): RAP-MD-01, RAP-MD-04, RAP-MD-06
(NOTE: 04 and 06 are open label extensions)

Age range: 18-65

Study summary: Coming soon

Major Depressive Disorder (Takeda)

Protocol(s): LuAA21004_402

Age range: 18-75

Study summary: The purpose of this study is to evaluate the efficacy of vortioxetine (5, 10, and 20 mg) versus placebo during the first 28 weeks of the 32-week double-blind treatment period in the prevention of relapse in participants with major depressive disorder (MDD) who responded to acute treatment with vortioxetine 10 mg.

Schizophrenia (Avanir)

Protocol(s): 15-AVP-786-202

Age range: 18-60

Study summary: The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability of AVP-786 as an adjunctive treatment compared with placebo in patients with residual schizophrenia.

Schizophrenia (Boehringer Ingelheim)

Protocol(s): 1346.9

Age range: 18-50

Study summary: The objective of the study is to investigate the efficacy, safety and pharmacokinetics of four different doses of BI 425809 once daily compared to placebo given for 12 weeks in patients with schizophrenia on stable antipsychotic treatment.

Schizophrenia, Recent-Onset (Janssen)

Protocol(s): R092670SCH3013

Age range: 18-35

Study summary: The purpose of the study is to compare effectiveness of paliperidone palmitate (PP: paliperidone palmitate once-monthly and 3-month injections) versus oral antipsychotic (OAP) on delaying time to treatment failure. The study will also evaluate changes in cognition, functioning, brain intracortical myelin (ICM) volume following treatment with PP compared with OAP in participants with recent-onset schizophrenia or schizophreniform disorder.

Schizophrenia, Treatment-Resistant (Lundbeck)

Protocol(s): 16159A

Age range: 18+

Study summary: To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)