CompletedNCT01377233Updated Mar 22, 2016Results posted

Study of the Safety, Tolerability, and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

A Phase 2 interventional study of Zicronapine open-label lead-in 10 mg daily and Zicronapine 10 mg daily in Schizophrenia, sponsored by H. Lundbeck A/S. Completed at 4 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-22.

Sponsored by H. Lundbeck A/S · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 46
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.

Read the detailed description

The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.

Conditions studied

Schizophrenia

Browse trials for

Schizophrenia 3,471

Keywords

Schizophrenia
Antipsychotic
Zicronapine
Lu 31-310

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 46 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

H. Lundbeck A/S is the lead sponsor of 218 studies on the registry; 10 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 10 (30%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
A score of \<=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
A total score >=60 on Positive and Negative Syndrome Scale (PANSS)
A score of \<=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)

Exclusion criteria

Exclusion Criteria:

Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
Significant risk of harming himself/herself or others
Positive serology for hepatitis A, B, C, or HIV
Present condition that might compromise liver function
Medical or neurological disorder or treatment that could interfere with study treatment or compliance
Previous exposure to zicronapine

Other inclusion and exclusion criteria may apply.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 46 participants (actual)

Study arms

Experimental
Zicronapine open-label lead-in 10 mg daily
Drug: Zicronapine open-label lead-in 10 mg daily
Experimental
Zicronapine 10 mg daily
Drug: Zicronapine 10 mg daily
Experimental
Zicronapine 20 mg once weekly
Drug: Zicronapine 20 mg once weekly
Experimental
Zicronapine 30 mg once weekly
Drug: Zicronapine 30 mg once weekly
Experimental
Zicronapine 45 mg once weekly
Drug: Zicronapine 45 mg once weekly

Interventions

DrugZicronapine open-label lead-in 10 mg daily
Encapsulated tablet ,10 mg, once daily, open-label
Also known as: Lu 31-130
DrugZicronapine 10 mg daily
Encapsulated tablet, 10 mg, once daily, double-blind
Also known as: Lu 31-130
DrugZicronapine 20 mg once weekly
Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Also known as: Lu 31-130
DrugZicronapine 30 mg once weekly
Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Also known as: Lu 31-130
DrugZicronapine 45 mg once weekly
Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
Also known as: Lu 31-130

What researchers measure

Primary outcomes

Number of Patients With Adverse Events as a Measure of Safety and Tolerability
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
Time frame: 11 weeks for open-label period; 13 weeks for double-blind period

Secondary outcomes

Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).
Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Clinical Global Impression Severity Scale (CGI-S) Change From Baseline
The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.
Time frame: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)

Results

Posted Mar 22, 2016

Participant flow

Open-label

Participant flow — Open-label
Milestone	Zicronapine Open-label 10 mg Daily	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Started	46	0	0	0	0
Completed	42	0	0	0	0
Not completed	4	0	0	0	0
Withdrew: Adverse event	1	0	0	0	0
Withdrew: Withdrawal by subject	3	0	0	0	0

Double-blind

Participant flow — Double-blind
Milestone	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Started	11	10	11	10
Completed	10	8	7	8
Not completed	1	2	4	2
Withdrew: Adverse event	1	2	2	0
Withdrew: Protocol violation	0	0	0	1
Withdrew: Withdrawal by subject	0	0	1	0
Withdrew: Administrative or other	0	0	1	1

Outcome measures

PrimaryNumber of Patients With Adverse Events as a Measure of Safety and Tolerability

Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)

Time frame:: 11 weeks for open-label period; 13 weeks for double-blind period
Reported as:: Number · participants

Number of Patients With Adverse Events as a Measure of Safety and Tolerability
participants	Zicronapine Open-label 10 mg Daily	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Number of Patients With Adverse Events as a Measure of Safety and Tolerability	12	8	4	4	9

SecondaryPositive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline

The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

Time frame:: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Reported as:: Mean · units on a scale

Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline
units on a scale	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
PANSS total	-8.0 ± 2.7	-8.7 ± 2.5	-10.6 ± 2.6	-12.2 ± 2.5
PANSS Positive Symptoms	-1.5 ± 1.1	-0.8 ± 1.0	-1.8 ± 1.1	-2.6 ± 1.0
PANSS Negative Symptoms	-2.9 ± 1.0	-2.8 ± 1.0	-2.0 ± 1.0	-3.1 ± 1.0
PANSS General Psychopathology	-5.2 ± 1.2	-5.5 ± 1.2	-6.4 ± 1.3	-6.2 ± 1.2

SecondaryClinical Global Impression Severity Scale (CGI-S) Change From Baseline

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses their clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).

Time frame:: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Reported as:: Mean · units on a scale

Clinical Global Impression Severity Scale (CGI-S) Change From Baseline
units on a scale	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Clinical Global Impression Severity Scale (CGI-S) Change From Baseline	-0.5 ± 0.2	-0.5 ± 0.2	-0.2 ± 0.2	-0.7 ± 0.2

SecondaryClinical Global Impression Improvement Scale (CGI-I)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment is made independent of whether the rater believes the improvement is drug-related or not.

Time frame:: 8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period)
Reported as:: Mean · units on a scale

Clinical Global Impression Improvement Scale (CGI-I)
units on a scale	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Clinical Global Impression Improvement Scale (CGI-I)	2.9 ± 0.6	3.4 ± 1.1	3.0 ± 0.6	2.9 ± 1.1

Adverse events

Collected over Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Zicronapine Open-label 10 mg Daily	—	0/46 (0%)	8/46 (17.4%)
Zicronapine Basis Dose 10 mg Daily	—	0/11 (0%)	8/11 (72.7%)
Zicronapine Low Dose 20 mg Once Weekly	—	1/10 (10%)	4/10 (40%)
Zicronapine Med Dose 30 mg Once Weekly	—	1/11 (9.1%)	4/11 (36.4%)
Zicronapine High Dose 45 mg Once Weekly	—	1/10 (10%)	9/10 (90%)

Most frequent serious events

Most frequent serious events
Event	Zicronapine Open-label 10 mg Daily	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
SchizophreniaPsychiatric disorders	0/46	0/11	0/10	1/11	1/10
Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders	0/46	0/11	1/10	0/11	0/10

Most frequent other events

Showing 10 of 33

Most frequent other events
Event	Zicronapine Open-label 10 mg Daily	Zicronapine Basis Dose 10 mg Daily	Zicronapine Low Dose 20 mg Once Weekly	Zicronapine Med Dose 30 mg Once Weekly	Zicronapine High Dose 45 mg Once Weekly
Accidental OverdoseInjury, poisoning and procedural complications	1/46	0/11	0/10	0/11	2/10
Weight IncreasedInvestigations	0/46	2/11	1/10	1/11	2/10
InsomniaPsychiatric disorders	1/46	1/11	2/10	0/11	1/10
DyspepsiaGastrointestinal disorders	0/46	0/11	1/10	0/11	0/10
Non-Cardiac Chest PainGeneral disorders	0/46	0/11	0/10	0/11	1/10
Urinary Tract InfectionInfections and infestations	0/46	0/11	0/10	0/11	1/10
Alanine Aminotransferase IncreasedInvestigations	0/46	0/11	1/10	0/11	0/10
Aspartate Aminotransferase IncreasedInvestigations	0/46	0/11	1/10	0/11	0/10
Weight DecreasedInvestigations	0/46	0/11	0/10	0/11	1/10
ArthralgiaMusculoskeletal and connective tissue disorders	0/46	0/11	0/10	0/11	1/10

Baseline characteristics

Baseline characteristics for the 4 patients enrolled in the open-label period but not randomized to the double blinded period, are reported in the first (open-label) study arm. Baseline characteristics for the 42 patients who were subsequently randomized to the double-blind period are reported across the last four (randomized) study arms.

Age, Continuous
Age, Continuous(years)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Mean	38.5 ± 6.6	42.7 ± 11.7	47.8 ± 6.4	50.8 ± 5.0	50.1 ± 4.8	47.0 ± 8.3

Sex: Female, Male
Sex: Female, Male(Participants)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Female	1	4	4	4	4	17
Male	3	7	6	7	6	29

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
American Indian or Alaska Native	1	0	0	0	0	1
Asian	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	1	0	0	1
Black or African American	1	7	5	8	7	28
White	2	4	4	3	3	16
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
United States	4	11	10	11	10	46

Height
Height(cm)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Mean	176.3 ± 9.4	169.5 ± 8.3	170.1 ± 9.7	174.6 ± 10.3	170.9 ± 11.7	171.8 ± 9.8

Weight
Weight(kg)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Mean	94.7 ± 27.5	90.0 ± 21.1	91.5 ± 19.2	87.5 ± 17.5	93.8 ± 16.8	89.7 ± 18.0

BMI
BMI(kg/m2)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Mean	30.0 ± 5.5	31.3 ± 7.1	31.6 ± 5.9	28.6 ± 4.2	32.2 ± 5.2	30.4 ± 5.3

Waist circumference
Waist circumference(cm)	Zicronapine Open-label 10 mg Daily	Zicronapine 10 mg Daily	Zicronapine 20 mg Once Weekly	Zicronapine 30 mg Once Weekly	Zicronapine 45 mg Once Weekly	Total
Mean	98.7 ± 16.2	99.8 ± 16.4	101.8 ± 14.1	101.1 ± 13.1	106.5 ± 12.5	103.3 ± 13.2

Study locations

4 sites

US002
Garden Grove, California 92845, United States
US003
National City, California 91950, United States
US004
San Diego, California 92102, United States
US001
Rockville, Maryland 20850, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01377233
Lead sponsor: H. Lundbeck A/S
Responsible party: Sponsor
First posted: Jun 21, 2011
Start date: Jul 2011
Primary completion: Feb 2012
Results posted: Mar 22, 2016
Last update: Mar 22, 2016

Study contacts

Email contact via H. Lundbeck A/S

study director · LundbeckClinicalTrials@lundbeck.com

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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