To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00150176
• Collaborator: (none)
• Enrollment: 831
• Arms: 2
• Duration (Months): 39

Study Details

Study Description

Brief Summary

Schizophrenia is a brain disease. The condition may be associated with acute psychotic episodes and long-term disability despite remission from the acute symptoms. Current management of schizophrenia focuses on the treatment of acute symptoms as well as long-term treatment aimed at preventing relapse after patients have experienced an improvement in acute symptoms. Patients who discontinue treatment have a high likelihood of experiencing relapse within 1-2 years after an acute episode of schizophrenia. Patients who remain on antipsychotic treatment have lower rates of relapse and have milder courses of exacerbation when relapse occurs.The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other. Asenapine may help to correct the imbalance in dopamine and serotonin. The purpose of this clinical trial is to evaluate the efficacy of asenapine in preventing relapse/impending relapse (hereafter referred to as 'relapse') in subjects who have been treated with asenapine for symptoms of schizophrenia for 26 weeks. In addition, to determine the safety and tolerability of asenapine for up to 1-year of treatment.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Asenapine - Open Label; Drug: Placebo - Double Blind; Drug: Asenapine - Double Blind	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 831 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Placebo-Controlled, Double-Blind Trial of Asenapine in the Prevention of Relapse After Long-Term Treatment of Schizophrenia
• Study Start Date: Apr 1, 2005
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: asenapine	Drug: Asenapine - Open Label; Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).; Other Names: Saphris, Org 5222, SCH 900274 ; Drug: Asenapine - Double Blind; Double Blind Phase: Following the Open Label Phase, asenapine 5 or 10 mg sublingual twice daily for 26 weeks.; Other Names: Org 5222, SCH 900274, Saphris
Placebo Comparator: placebo	Drug: Asenapine - Open Label; Open Label Phase: All subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1).; Other Names: Saphris, Org 5222, SCH 900274 ; Drug: Placebo - Double Blind; Double Blind Phase: Following Open Label Phase, matching placebo sublingual twice daily for 26 weeks.

Outcome Measures

Primary Outcome Measures

1. Time to Relapse or an Impending Relapse [time of first relapse up to Day 182 (double blind phase)]

   A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

Secondary Outcome Measures

1. Time to Early Discontinuation for Any Reason [time of discontinuation up to Day 182 (double blind phase)]

   The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Have a primary diagnosis of schizophrenia

• History of at least 1 prior episode of acute schizophrenia in the 3 years preceding screening

• History of schizophrenia requiring continuous antipsychotic treatment for at least 1 years preceding screening

• Clinically stable at the time of entry defined by at least a 4 week period of stable symptoms

Key Exclusion Criteria:

• Have an uncontrolled, unstable clinically significant medical condition

• History of suicide attempt or significant violence to others in the past 2 years

• A substance-induced psychotic disorder or behavioral disturbance thought to be due to substance abuse

• Current substance abuse/dependence

• Concurrent psychiatric disorder other than schizophrenia.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00150176
• Other Study ID Numbers: P05770; A7501012
• First Posted: Sep 8, 2005
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Schizophrenia; Asenapine

Study Results

Participant Flow

Pre-assignment Detail	Prior to randomization, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). Only subjects who had continued stable presentation of symptoms during this phase were randomized into the double-blind phase.

Arm/Group Title	Asenapine	Placebo
Arm/Group Description	Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Period Title: Overall Study
STARTED	194	192
COMPLETED	135	72
NOT COMPLETED	59	120

Baseline Characteristics

Arm/Group Title	Asenapine	Placebo	Total
Arm/Group Description	Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.	Total of all reporting groups
Overall Participants	194	192	386
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.2 (12.53)	38.7 (11.64)	38.9 (12.08)
Sex: Female, Male (Count of Participants)
Female	89 45.9%	76 39.6%	165 42.7%
Male	105 54.1%	116 60.4%	221 57.3%

Outcome Measures

1. Primary Outcome

Title	Time to Relapse or an Impending Relapse
Description	A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.
Time Frame	time of first relapse up to Day 182 (double blind phase)

Outcome Measure Data

Analysis Population Description

ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed & subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing >3 days after last dose also excluded.

Arm/Group Title	Asenapine	Placebo
Arm/Group Description	Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Measure Participants	190	190
Days 1 - 7 (N asenapine = 190; N placebo = 190)	0	3
Days 8 - 14 (N asenapine = 188; N placebo = 186)	1	14
Days 15 - 21 (N asenapine = 183; N placebo = 170)	2	9
Days 22 - 28 (N asenapine = 180; N placebo = 160)	2	8
Days 29 - 35 (N asenapine = 175; N placebo = 149)	0	7
Days 36 - 42 (N asenapine = 175; N placebo = 140)	1	8
Days 43 - 49 (N asenapine = 173; N placebo = 130)	5	2
Days 50 - 56 (N asenapine = 166; N placebo = 127)	1	4
Days 57 - 63 (N asenapine = 165; N placebo = 123)	1	1
Days 64 - 70 (N asenapine = 163; N placebo = 120)	2	3
Days 71 - 77 (N asenapine = 161; N placebo = 117)	1	4
Days 78 - 84 (N asenapine = 160; N placebo = 113)	2	2
Days 85 - 91 (N asenapine = 158; N placebo = 110)	0	4
Days 92 - 98 (N asenapine = 154; N placebo = 104)	0	4
Days 99 - 105 (N asenapine = 151; N placebo = 99)	0	2
Days 106 - 112 (N asenapine = 151; N placebo = 96)	0	1
Days 113 - 119 (N asenapine = 149; N placebo = 95)	2	3
Days 120 - 126 (N asenapine = 147; N placebo = 87)	0	1
Days 127 - 133 (N asenapine = 147; N placebo = 86)	0	1
Days 134 - 140 (N asenapine = 146; N placebo = 84)	0	0
Days 141 - 147 (N asenapine = 145; N placebo = 83)	0	1
Days 148 - 154 (N asenapine = 142; N placebo = 81)	0	5
Days 155 - 161 (N asenapine = 141; N placebo = 75)	0	1
Days 162 - 168 (N asenapine = 139; N placebo = 74)	1	0
Days 169 - 175 (N asenapine = 137; N placebo = 72)	2	1
Days 176 - 182 (N asenapine = 135; N placebo = 70)	0	1
Days 183 - 189 (N asenapine = 75; N placebo = 39)	0	0
Days 190 - 196 (N asenapine = 9; N placebo = 9)	0	0
Days 197 - 203 (N asenapine = 2; N placebo = 2)	0	0
Days 204 - 210 (N asenapine = 0; N placebo = 1)	0	0

2. Secondary Outcome

Title	Time to Early Discontinuation for Any Reason
Description	The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).
Time Frame	time of discontinuation up to Day 182 (double blind phase)

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.

Arm/Group Title	Asenapine	Placebo
Arm/Group Description	Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Measure Participants	191	191
Days 1 - 7 (N asenapine = 191; N placebo = 191)	1 0.5%	2 1%
Days 8 - 14 (N asenapine = 190; N placebo = 189)	6 3.1%	14 7.3%
Days 15 - 21 (N asenapine = 184; N placebo = 175)	3 1.5%	10 5.2%
Days 22 - 28 (N asenapine = 181; N placebo = 165)	5 2.6%	11 5.7%
Days 29 - 35 (N asenapine = 176; N placebo = 154)	0 0%	11 5.7%
Days 36 - 42 (N asenapine = 176; N placebo = 143)	3 1.5%	7 3.6%
Days 43 - 49 (N asenapine = 173; N placebo = 136)	7 3.6%	7 3.6%
Days 50 - 56 (N asenapine = 166; N placebo = 129)	0 0%	3 1.6%
Days 57 - 63 (N asenapine = 166; N placebo = 126)	3 1.5%	4 2.1%
Days 64 - 70 (N asenapine = 163; N placebo = 122)	1 0.5%	2 1%
Days 71 - 77 (N asenapine = 162; N placebo = 120)	0 0%	4 2.1%
Days 78 - 84 (N asenapine = 162; N placebo = 116)	4 2.1%	3 1.6%
Days 85 - 91 (N asenapine = 158; N placebo = 113)	5 2.6%	8 4.2%
Days 92 - 98 (N asenapine = 153; N placebo = 105)	2 1%	4 2.1%
Days 99 - 105 (N asenapine = 150; N placebo = 100)	0 0%	2 1%
Days 106 - 112 (N asenapine = 150; N placebo = 98)	1 0.5%	1 0.5%
Days 113 - 119 (N asenapine = 149; N placebo = 97)	1 0.5%	8 4.2%
Days 120 - 126 (N asenapine = 148; N placebo = 88)	0 0%	1 0.5%
Days 127 - 133 (N asenapine = 148; N placebo = 87)	2 1%	0 0%
Days 134 - 140 (N asenapine = 146; N placebo = 86)	0 0%	1 0.5%
Days 141 - 147 (N asenapine = 145; N placebo = 84)	3 1.5%	1 0.5%
Days 148 - 154 (N asenapine = 142; N placebo = 82)	1 0.5%	3 1.6%
Days 155 - 161 (N asenapine = 141; N placebo = 78)	1 0.5%	3 1.6%
Days 162 - 168 (N asenapine = 139; N placebo = 75)	2 1%	1 0.5%
Days 169 - 175 (N asenapine = 137; N placebo = 73)	2 1%	1 0.5%
Days 176 - 182 (N asenapine = 135; N placebo = 71)	0 0%	1 0.5%
Days 183 - 189 (N asenapine = 75; N placebo = 39)	0 0%	0 0%
Days 190 - 196 (N asenapine = 9; N placebo = 9)	0 0%	0 0%
Days 197 - 203 (N asenapine = 2; N placebo = 2)	0 0%	0 0%
Days 204 - 210 (N asenapine = 0; N placebo = 1)	0 0%	0 0%

Adverse Events

Time Frame	Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled).
Adverse Event Reporting Description	During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Arm/Group Title	Asenapine		Placebo		Asenapine During Open-Label Phase and Not Randomized
Arm/Group Description	Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.		Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.		Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
All Cause Mortality
	Asenapine		Placebo		Asenapine During Open-Label Phase and Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Asenapine		Placebo		Asenapine During Open-Label Phase and Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/194 (3.1%)		22/192 (11.5%)		39/314 (12.4%)
Gastrointestinal disorders
DYSPHAGIA	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
INGUINAL HERNIA, OBSTRUCTIVE	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
General disorders
HYPOTHERMIA	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
NON-CARDIAC CHEST PAIN	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Infections and infestations
ADNEXITIS	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
APPENDICITIS	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
BRONCHITIS	0/194 (0%)	0	0/192 (0%)	0	2/314 (0.6%)	2
EXTERNAL EAR CELLULITIS	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
GASTROENTERITIS	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
PNEUMONIA	0/194 (0%)	0	0/192 (0%)	0	2/314 (0.6%)	2
SEPSIS	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
FALL	1/194 (0.5%)	1	0/192 (0%)	0	0/314 (0%)	0
OVERDOSE	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
RADIUS FRACTURE	1/194 (0.5%)	1	0/192 (0%)	0	0/314 (0%)	0
ROAD TRAFFIC ACCIDENT	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
SPINAL CORD INJURY	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Investigations
BLOOD GLUCOSE DECREASED	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
Metabolism and nutrition disorders
DIABETES MELLITUS	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
DIABETES MELLITUS INADEQUATE CONTROL	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
HYPOGLYCAEMIA	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Nervous system disorders
CONVULSION	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
DISTURBANCE IN ATTENTION	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
POOR QUALITY SLEEP	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
TARDIVE DYSKINESIA	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
UNRESPONSIVE TO STIMULI	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Psychiatric disorders
AGITATION	0/194 (0%)	0	0/192 (0%)	0	2/314 (0.6%)	2
ANXIETY	1/194 (0.5%)	1	0/192 (0%)	0	0/314 (0%)	0
DEPRESSIVE SYMPTOM	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
HALLUCINATION, AUDITORY	0/194 (0%)	0	1/192 (0.5%)	1	1/314 (0.3%)	1
HALLUCINATION, VISUAL	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
HOMICIDAL IDEATION	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
MAJOR DEPRESSION	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
PARANOIA	0/194 (0%)	0	1/192 (0.5%)	1	1/314 (0.3%)	1
PSYCHOTIC DISORDER	0/194 (0%)	0	0/192 (0%)	0	2/314 (0.6%)	2
SCHIZOPHRENIA	2/194 (1%)	2	9/192 (4.7%)	9	10/314 (3.2%)	11
SCHIZOPHRENIA, PARANOID TYPE	2/194 (1%)	2	7/192 (3.6%)	7	11/314 (3.5%)	11
SCHIZOPHRENIA, UNDIFFERENTIATED TYPE	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
SUICIDAL IDEATION	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
SUICIDE ATTEMPT	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
THINKING ABNORMAL	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Reproductive system and breast disorders
BALANOPOSTHITIS	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Skin and subcutaneous tissue disorders
STEVENS-JOHNSON SYNDROME	0/194 (0%)	0	0/192 (0%)	0	1/314 (0.3%)	1
Vascular disorders
HYPERTENSION	0/194 (0%)	0	1/192 (0.5%)	1	0/314 (0%)	0
Other (Not Including Serious) Adverse Events
	Asenapine		Placebo		Asenapine During Open-Label Phase and Not Randomized
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	121/194 (62.4%)		127/192 (66.1%)		170/314 (54.1%)
Gastrointestinal disorders
HYPOAESTHESIA ORAL	4/194 (2.1%)	5	10/192 (5.2%)	11	11/314 (3.5%)	11
NAUSEA	9/194 (4.6%)	10	10/192 (5.2%)	10	15/314 (4.8%)	15
Investigations
WEIGHT DECREASED	13/194 (6.7%)	13	21/192 (10.9%)	24	3/314 (1%)	3
WEIGHT INCREASED	28/194 (14.4%)	30	21/192 (10.9%)	23	11/314 (3.5%)	11
Nervous system disorders
AKATHISIA	13/194 (6.7%)	23	13/192 (6.8%)	20	21/314 (6.7%)	32
HEADACHE	21/194 (10.8%)	33	19/192 (9.9%)	28	19/314 (6.1%)	45
PARKINSONISM	10/194 (5.2%)	14	12/192 (6.3%)	18	12/314 (3.8%)	19
SEDATION	10/194 (5.2%)	14	10/192 (5.2%)	13	12/314 (3.8%)	16
SOMNOLENCE	31/194 (16%)	43	33/192 (17.2%)	47	54/314 (17.2%)	65
Psychiatric disorders
AGITATION	12/194 (6.2%)	13	19/192 (9.9%)	20	24/314 (7.6%)	29
ANXIETY	25/194 (12.9%)	32	27/192 (14.1%)	46	34/314 (10.8%)	48
DELUSION	2/194 (1%)	2	12/192 (6.3%)	15	12/314 (3.8%)	13
DEPRESSION	13/194 (6.7%)	14	9/192 (4.7%)	12	15/314 (4.8%)	20
HALLUCINATION	2/194 (1%)	2	13/192 (6.8%)	15	6/314 (1.9%)	6
INSOMNIA	39/194 (20.1%)	48	47/192 (24.5%)	64	42/314 (13.4%)	56
SCHIZOPHRENIA	8/194 (4.1%)	8	25/192 (13%)	32	8/314 (2.5%)	9

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor will be provided an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed. Materials for intended disclosure must be provided to sponsor at least 30 days before they are submitted for publication or otherwise disclosed. If any patent action is required to protect intellectual property rights, then the disclosure must be delayed for a period not to exceed an additional 60 days.