Trial Outcomes & Findings for Asenapine in the Treatment of Older Adults With Bipolar Disorder (NCT NCT01460290)

NCT ID: NCT01460290

Last Updated: 2014-12-30

Results Overview

The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 15 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2014-12-30

Participant Flow

Participant milestones

Measure	Asenapine 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Overall Study STARTED	15
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Asenapine 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Overall Study Adverse Event	3
Overall Study Elevated liver function	1

Baseline Characteristics

Asenapine in the Treatment of Older Adults With Bipolar Disorder

Baseline characteristics by cohort

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Age, Continuous	68.6 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants with baseline HAM-D score of 8 or greater were analyzed. Last Observational Carried Forward (LOCF).

The minimum possible score is 0 and the maximum score is 52. A higher score implies a worse condition.

Outcome measures

Measure	Asenapine n=11 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) Baseline HAM-D	17.5 units on a scale Standard Deviation 4.8
Change in Depressive Symptoms as Measured by the Hamilton Depression Rating Scale (HAM-D) 12 Week HAM-D	10.3 units on a scale Standard Deviation 6.3

PRIMARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants with a baseline YMRS score of 12 or greater were analyzed. LOCF

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Outcome measures

Measure	Asenapine n=5 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) Baseline YMRS	27.9 units on a scale Standard Deviation 4.4
Change in Manic Symptoms as Measured by the Young Mania Rating Scale (YMRS) 12 Week YMRS	18.1 units on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Intention To Treat (ITT) and LOCF

The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

The CGI-BP has three scores - Mania Severity, Depression Severity, and Overall Bipolar Illness Severity.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) Baseline Overall Severity	4.4 units on a scale Standard Deviation 1.0
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) 12 Week Overall Severity	2.2 units on a scale Standard Deviation 1.0
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) Baseline Mania Severity	2.7 units on a scale Standard Deviation 1.7
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) 12 Week Mania Severity	1.9 units on a scale Standard Deviation 1.1
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) Baseline Depression Severity	3.6 units on a scale Standard Deviation 1.5
Change in Global Psychopathology as Measured by the Clinical Global Impression Scale for Use in Bipolar Illness (CGI-BP) 12 Week Depression Severity	1.7 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT and LOCF.

The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) Baseline on Physical Health Subscale of SF-12	46.8 units on a scale Standard Deviation 11.3
Change in Perception of Physical Health as Measured by the Short Form General Health Survey (SF-12) 12 week on Physical Health Subscale of SF-12	46.4 units on a scale Standard Deviation 12.1

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT and LOCF.

The minimum possible score is 1 and the maximum score is 99. A higher score implies a better perceived condition.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) Baseline Mental Health Subscore of SF-12	38.7 units on a scale Standard Deviation 15.3
Change in Perception of Mental Health as Measured by the Short Form General Health Survey (SF-12) 12 Week Mental Health Subscore of SF-12	43.1 units on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants with a baseline MADRS score of 16 or greater were analyzed. LOCF

The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) Baseline MADRS	27.9 units on a scale Standard Deviation 4.4
Change in Depressive Symptoms as Measured by the Montgomery Asberg Depression Rating Scale (MADRS) 12 Week MADRS	18.1 units on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT and LOCF.

The minimum possible score is 18 and the maximum score is 126. A higher score implies a worse condition.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) Baseline BPRS	35.1 units on a scale Standard Deviation 9.2
Change in Bipolar Disorder Symptoms as Measured by the Brief Psychiatric Rating Scale (BPRS) 12 Week BPRS	28.6 units on a scale Standard Deviation 9.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

The Stroop evaluates patients for cognitive functioning. Patients are to read words aloud or name colors as quickly as possible in a 45-second period. The measure contains three tasks, each associated with a subscale as follows: Word, Color, and Color-Word. Each subscale contains 100 items. The raw score range for each of the subscales is 0-100. Each raw subscale score is converted to a T-Score. The possible T-Score range for the Word subscale is 15 to 85. The possible T-Score range for the Color subscale is 8 to 92. The possible T-Score range for the Color-Word subscale is 3 to 98. Higher scores on the subscales indicate better cognitive functioning. Subscales are scored independently and are not added to produce a total score.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Stroop Task Baseline Word Subscale	75.7 T-Score Standard Deviation 12.0
Change in Cognitive Status as Measured by the Stroop Task 12 Week Word Subscale	75.9 T-Score Standard Deviation 11.5
Change in Cognitive Status as Measured by the Stroop Task Baseline Color Subscale	53.6 T-Score Standard Deviation 9.2
Change in Cognitive Status as Measured by the Stroop Task 12 Week Color Subscale	58.6 T-Score Standard Deviation 7.7
Change in Cognitive Status as Measured by the Stroop Task Baseline Color-Word Subscale	30.3 T-Score Standard Deviation 11.4
Change in Cognitive Status as Measured by the Stroop Task 12 Week Color-Word Subscale	30.6 T-Score Standard Deviation 10.1

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

The Trails test is a measure of cognitive functioning. The measure consists of two parts: A and B. In part A, participants are asked to draw a trail connecting a series of numbers in sequential order. In Part B, participants are asked to draw a trail connecting a combination of letters and numbers. The time taken to complete each task is noted as the score (e.g., 78 seconds). For Trails A, there is no upper limit on the score, as subjects are given as much time as is needed for them to complete the task. Higher scores indicate poorer cognitive functioning. In Trails B, the task is timed with an upper limit of five minutes. If, at four minutes, it is determined that the subject will not likely complete the task in the time allotted, then the task can be called off. Higher scores indicate poorer cognitive functioning.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Trail Making Test Baseline Trails - Part A	57.7 seconds Standard Deviation 30.9
Change in Cognitive Status as Measured by the Trail Making Test 12 Week Trails - Part A	47.3 seconds Standard Deviation 10.4
Change in Cognitive Status as Measured by the Trail Making Test Baseline Trails - Part B	189.0 seconds Standard Deviation 103.8
Change in Cognitive Status as Measured by the Trail Making Test 12 Week Trails - Part B	126.3 seconds Standard Deviation 52.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-36). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.

Total recall scores appear in this entry below.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) Baseline HVLT Total Recall	15.8 correctly recalled items Standard Deviation 5.7
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) 12 Week HVLT Total Recall	18.2 correctly recalled items Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

The DRS contains items that evaluate cognitive function across 5 subscales: attention, initiation/perseveration, construction, conceptualization, and memory. Subscale raw score ranges are: attention (0-37), initiation/perseveration (0-37), construction (0-6), conceptualization (0-39), and memory (0-25). Raw subscale scores are added for a total raw score with range 0-144. For each raw subscale score, scaled scores are looked up from a battery of 13 tables. Age of the participant determines which table is to be used. Total raw subscale score also has its own scaled score in the tables. In addition to use in determining scaled scores for each of the subscales, these tables are used to look up the scaled score for the total raw score. The tables are contained in the article Robust and Expanded Norms for the Dementia Rating Scale (Pedraza, Lucas, et al. 2010); Archives of Clinical Neuropsychology 25; 347-358. Higher scores, raw and scaled, indicate better cognitive functioning.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS) Baseline DRS	131.2 units on a scale Standard Deviation 6.6
Change in Cognitive Status as Measured by the Dementia Rating Scale (DRS) 12 Week DRS	135.6 units on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT and LOCF.

The WHO-DAS II is used to assess patients for difficulties that they experience due to health conditions. Six subscales are represented which cover the following domains: Getting Around (range 1-10), Self Care (range 1-10), Life Activities (range 1-20), Understand/Communicate (range 1-10), Participation in Society (range 1-10), and Getting Along with People (range 1-10). Lower scores represent more positive outcomes, while higher scores represent worse outcomes. Total summary scores were not computed for our analyses and is optional for the measure.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Getting Around Subscale	4.3 units on a scale Standard Deviation 2.7
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Getting Around Subscale	4.7 units on a scale Standard Deviation 2.9
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Self Care Subscale	2.6 units on a scale Standard Deviation 1.3
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Self Care Subscale	2.4 units on a scale Standard Deviation 0.7
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Life Activities Subscale	9.1 units on a scale Standard Deviation 4.9
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Life Activities Subscale	7.1 units on a scale Standard Deviation 3.5
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Understand/Communicate Subscale	3.6 units on a scale Standard Deviation 1.8
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Understand/Communicate Subscale	3.1 units on a scale Standard Deviation 1.2
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Participation in Society Subscale	4.3 units on a scale Standard Deviation 2.6
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Participation in Society Subscale	3.8 units on a scale Standard Deviation 2.0
World Health Organization Disability Assessment Scale (WHO-DAS) Baseline WHO-DAS Getting Along w/ People Subscale	3.0 units on a scale Standard Deviation 1.5
World Health Organization Disability Assessment Scale (WHO-DAS) 12 Week WHO-DAS Getting Along w/ People Subscale	2.9 units on a scale Standard Deviation 1.9

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT and LOCF.

This scale is used to measure the presence of akathisia, as may result from use of certain psychotropic medications. The scale contains four items and the score for each item is added to produce the total score. Total scores range from 0 to 14. Higher scores indicate more adverse outcomes.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Barnes Drug-induced Akathisia Rating Scale (BARS) Baseline BARS	0.0 units on a scale Standard Deviation 0.0
Barnes Drug-induced Akathisia Rating Scale (BARS) 12 Week BARS	0.1 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: ITT and LOCF.

The Simpson-Angus Scale is used to monitor for neurological and musculoskeletal side effects that may be a result of certain psychotropic medications. The scale consists of 10 questions which each can be rated on a scale of 0 to 4. Scores for each item are added to produce a total score. The highest possible total score is 40. Higher scores indicate more adverse outcomes.

Outcome measures

Measure	Asenapine n=15 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS) Baseline SAS	0.4 units on a scale Standard Deviation 0.8
Assessment of Motor Control Abnormality as Measured by the Simpson Angus Scale (SAS) 12 Week SAS	0.5 units on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.

Delayed recall scores appear in this entry below.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) Baseline HVLT Delayed Recall	5.2 correctly recalled items Standard Deviation 3.0
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) 12 Week HVLT Delayed Recall	5.3 correctly recalled items Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.

Retention scores appear in this entry below.

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) Baseline HVLT Retention	73.9 percentage of items Standard Deviation 32.7
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) 12 Week HVLT Retention	71.8 percentage of items Standard Deviation 34.4

SECONDARY outcome

Timeframe: Baseline and 12 weeks

Population: Participants who completed cognitive scales at baseline and at Week 12 visit were analyzed.

Evaluates cognitive functioning across domains: recall, delayed recall, retention, recognition (each scored separately). The scores given are titled: recall score, delayed recall score, retention score, recognition discrimination index. Total Recall score = items correctly recalled (0-12). Delayed Recall score = items correctly recalled following delay (0-12). Retention score = percent items recalled that were also recalled after delay (0-100). The Recognition Discrimination score = true positives minus false positives (0-12). Recall task has 12 words and involves to recall of words after all of them are read aloud to the patient. Delayed recall tasks involves the same twelve words, except recall is tasked after a 20-25 minute delay. Recognition task has 24 words. Patient evaluated on how many from original list he or she is able to recognize. Higher scores = better outcomes.

Recognition Discrimination Index appears in this entry below

Outcome measures

Measure	Asenapine n=9 Participants 12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) Baseline HVLT Recognition Discrimation Index	8.6 number of items Standard Deviation 2.5
Change in Cognitive Status as Measured by the Hopkins Verbal Learning Test (HVLT) 12 Week HVLT Recognition Discrimination Index	9.6 number of items Standard Deviation 2.0

Adverse Events

Asenapine

Serious events: 3 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Asenapine n=15 participants at risk 12-weeks of open-label asenapine treatment Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.
Psychiatric disorders emergence of manic symptoms	6.7% 1/15 • Number of events 1
Psychiatric disorders recurrence of suicidal ideation	6.7% 1/15 • Number of events 1
Psychiatric disorders reported dizziness/refusal to take additional mood stabilizer	6.7% 1/15 • Number of events 1

Other adverse events

Measure	Asenapine n=15 participants at risk 12-weeks of open-label asenapine treatment Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.
Hepatobiliary disorders elevated liver functions	6.7% 1/15 • Number of events 1
Gastrointestinal disorders gastrointestinal discomfort	33.3% 5/15 • Number of events 5
General disorders restlessness	13.3% 2/15 • Number of events 2
General disorders tremors	13.3% 2/15 • Number of events 2
General disorders cognitive difficulties	13.3% 2/15 • Number of events 2
General disorders sluggishness/sedation	13.3% 2/15 • Number of events 2

Additional Information

Martha Sajatovic, Professor of Psychiatry

University Hospitals of Cleveland

Phone: 2168442808

Email: martha.sajatovic@uhhospitals.org

Results disclosure agreements

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