Trial Outcomes & Findings for Biosignatures of Latuda for Bipolar Depression (NCT NCT02239094)

NCT ID: NCT02239094

Last Updated: 2017-12-12

Results Overview

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression. Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2017-12-12

Participant Flow

Participant milestones

Measure	Lurasidone (Latuda) All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Overall Study STARTED	20
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Lurasidone (Latuda) All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Overall Study Withdrawal by Subject	1
Overall Study Remitted before started	1

Baseline Characteristics

Biosignatures of Latuda for Bipolar Depression

Baseline characteristics by cohort

Measure	Lurasidone (Latuda) n=18 Participants All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.4 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Region of Enrollment United States	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.

Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).

Outcome measures

Measure	Lurasidone (Latuda) n=18 Participants All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Montgomery-Asberg Rating Scale for Depression (MADRS)	24.3 units on a scale Standard Deviation 6.4

PRIMARY outcome

Timeframe: Week 8

The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item clinician-administered scale, designed to be particularly sensitive to antidepressant treatment effects in patients with major depression.

Nine of the items are based upon patient report, and one is on the rater's observation during the rating interview. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe).

Outcome measures

Measure	Lurasidone (Latuda) n=18 Participants All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Montgomery-Asberg Rating Scale for Depression (MADRS) at Week8	8 units on a scale Standard Deviation 8.2

Adverse Events

Lurasidone (Latuda)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lurasidone (Latuda) n=18 participants at risk All study participants will receive open-label Latuda. Lurasidone (Latuda): Antipsychotic medication approved for use with Bipolar disorder
Nervous system disorders Headache	11.1% 2/18 • Number of events 2 • Adverse event was carefully monitored throughout the whole study period (8 Weeks)
General disorders Fatigue	5.6% 1/18 • Number of events 1 • Adverse event was carefully monitored throughout the whole study period (8 Weeks)
Gastrointestinal disorders Nausea	11.1% 2/18 • Number of events 5 • Adverse event was carefully monitored throughout the whole study period (8 Weeks)
Metabolism and nutrition disorders Weight Gain	16.7% 3/18 • Number of events 3 • Adverse event was carefully monitored throughout the whole study period (8 Weeks)

Additional Information

David J. Hellerstein

Depression Evaluation Service (New York State Psychiatric Institute)

Phone: 646-774-8069

Email: david.hellerstein@nyspi.columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place