History of Changes for Study: NCT03669640

A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms

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Study Record Versions

Version	Submitted Date	Changes
1	September 12, 2018	None (earliest Version on record)
2	October 10, 2018	Contacts/Locations, Study Status and Oversight
3	November 9, 2018	Recruitment Status, Study Status and Contacts/Locations
4	December 10, 2018	Study Status and Contacts/Locations
5	January 9, 2019	Contacts/Locations and Study Status
6	February 6, 2019	Study Status and Contacts/Locations
7	March 6, 2019	Contacts/Locations and Study Status
8	April 4, 2019	Contacts/Locations and Study Status
9	May 2, 2019	Study Status and Contacts/Locations
10	June 3, 2019	Study Status
11	June 25, 2019	Contacts/Locations, Eligibility and Study Status
12	July 25, 2019	Study Status and Contacts/Locations
13	August 22, 2019	Study Status and Contacts/Locations
14	September 20, 2019	Study Status
15	October 17, 2019	Study Status
16	November 13, 2019	Study Status and Contacts/Locations
17	December 11, 2019	Contacts/Locations and Study Status
18	January 9, 2020	Contacts/Locations and Study Status
19	February 7, 2020	Contacts/Locations and Study Status
20	March 6, 2020	Study Status
21	April 1, 2020	Study Status
22	May 1, 2020	Study Status
23	May 29, 2020	Study Status
24	June 26, 2020	Study Status and Contacts/Locations
25	August 5, 2020	Study Status, Contacts/Locations and Eligibility
26	September 2, 2020	Study Status
27	September 29, 2020	Contacts/Locations and Study Status
28	October 23, 2020	Study Status, Contacts/Locations, Study Identification, Eligibility, Outcome Measures, Arms and Interventions and Study Design
29	November 18, 2020	Study Status and Contacts/Locations
30	December 17, 2020	Study Status and Contacts/Locations
31	January 13, 2021	Study Status and Contacts/Locations
32	February 9, 2021	Study Status and Contacts/Locations
33	March 3, 2021	Study Status and Contacts/Locations
34	April 1, 2021	Study Status and Contacts/Locations
35	April 26, 2021	Contacts/Locations and Study Status
36	May 25, 2021	Contacts/Locations and Study Status
37	June 21, 2021	Study Status and Contacts/Locations
38	July 21, 2021	Contacts/Locations and Study Status
39	August 18, 2021	Contacts/Locations and Study Status
40	September 17, 2021	Contacts/Locations and Study Status
41	October 14, 2021	Contacts/Locations, Study Status and Eligibility
42	November 10, 2021	Contacts/Locations and Study Status
43	December 9, 2021	Study Status
44	January 7, 2022	Contacts/Locations and Study Status
45	February 4, 2022	Study Status and Contacts/Locations
46	March 4, 2022	Study Status and Contacts/Locations
47	April 1, 2022	Study Status and Contacts/Locations
48	April 29, 2022	Contacts/Locations and Study Status
49	June 3, 2022	Contacts/Locations and Study Status
50	July 1, 2022	Contacts/Locations and Study Status
51	July 26, 2022	Contacts/Locations and Study Status
52	August 19, 2022	Study Status and Contacts/Locations
53	September 13, 2022	Study Status
54	October 11, 2022	Study Status and Contacts/Locations
55	November 9, 2022	Study Status
56	December 8, 2022	Study Status and Contacts/Locations
57	January 6, 2023	Contacts/Locations and Study Status
58	February 2, 2023	Contacts/Locations and Study Status
59	March 2, 2023	Study Status and Contacts/Locations
60	March 29, 2023	Contacts/Locations and Study Status
61	April 17, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design
62	May 16, 2023	Recruitment Status, Study Status and Contacts/Locations
63	March 8, 2024	Quality Control Review has not concluded Returned: April 4, 2024 Recruitment Status, Study Status, Outcome Measures, Document Section, Results, Contacts/Locations and Study Design

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Study Identification


Unique Protocol ID:	BP40283
Brief Title:	A Study to Assess the Effects of RO6889450 (Ralmitaront) in Participants With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Official Title:	Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Effects of RO6889450 (Ralmitaront) in Patients With Schizophrenia or Schizoaffective Disorder and Negative Symptoms
Secondary IDs:

Study Status


Record Verification:	April May 2023
Overall Status:	Active, not recruiting Terminated [This study was discontinued due to an interim analysis which indicated that ralmitaront was unlikely to meet its primary endpoint.]
Study Start:	December 4, 2018
Primary Completion:	December 29, 2023 [Anticipated] March 31, 2023 [Actual]
Study Completion:	December 29, 2023 [Anticipated] May 8, 2023 [Actual]

First Submitted:	September 12, 2018
First Submitted that Met QC Criteria:	September 12, 2018
First Posted:	September 13, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	April 17 May 16, 2023
Last Update Posted:	April 19 May 18, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Hoffmann-La Roche
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description


Brief Summary:	This study investigates the effects of RO6889450 on the negative symptoms associated with schizophrenia and schizoaffective disorder.
Detailed Description:

Conditions


Conditions:	Schizophrenia, Schizoaffective Disorder
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	128 [Actual]

Arms and Interventions

Arms	Assigned Interventions
Experimental: Part A: Monotherapy Participants will receive RO6889450 or a dose-matched placebo. NOTE: Part A has completed enrollment.	Drug: RO6889450 Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks. Drug: Placebo Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.
Experimental: Part B: Add-On Therapy Participants will receive a low or high dose of RO6889450 or a dose-matched placebo in addition to their usual anti-psychotic treatment(s).	Drug: RO6889450 Participants will receive a once-daily, oral dose of RO6889450 for 12 weeks. Drug: Placebo Participants will receive a once-daily, oral dose of placebo matched to RO6889450 for 12 weeks.

Outcome Measures


Primary Outcome Measures:
1.	Change from Baseline at Week 12 in Brief Negative Symptoms Scale (BNSS) Avolition/Apathy Subscore [ Time Frame: Baseline to Week 12 ]
Secondary Outcome Measures:
1.	Change from Baseline in Clinical Global Impression Severity (CGI-S) Overall Scores [ Time Frame: Baseline to week 12 ]
2.	Change from Baseline in CGI-S Negative Symptoms Scores [ Time Frame: Baseline to week 12 ]
3.	Clinical Global Impression - Improvement (CGI-I) Overall Scores [ Time Frame: Week 12 ]
4.	CGI-I Negative Symptoms Scores [ Time Frame: Week 12 ]
5.	Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores [ Time Frame: Baseline to week 12 ]
6.	Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
7.	Change from Baseline in Brief Negative Symptom Scale (BNSS) Total Scores [ Time Frame: Baseline to week 12 ]
8.	Change from Baseline in Brief Negative Symptom Scale (BNSS) Symptom Factor Scores [ Time Frame: Baseline to week 12 ]
9.	Change from Baseline in Defeatist Performance Attitude Scale (DPAS) Scores [ Time Frame: Baseline to week 12 ]
10.	Percentage of Participants with Adverse Events (AE) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
11.	Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Scores [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
12.	Change from Baseline in Extrapyramidal Symptom Rating Scale, Abbreviated (ESRS-A) [ Time Frame: Baseline through the end of the follow-up period (approximately 16 weeks) ]
13.	Area Under the Curve at Steady State (AUCss) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]
14.	Maximum Serum Concentration (Cmax) of RO6889450 [ Time Frame: At pre-defined intervals from Day 7 through the end of the follow-up period (approximately 16 weeks) ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	55 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Patients with a Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of schizophrenia or schizoaffective disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI) Part B only: Stable treatment with a dopamine/serotonin (D2/5HT2A) antagonist or pure D2 antagonist(s), or a D2 partial agonist for a minimum of 6 months and receiving no more than two antipsychotics Medically stable during the 3 months prior to study entry Participant is an outpatient with no psychiatric hospitalizations within the prior 6 months PANSS negative symptom factor score of 18 or higher The following rating on items of the PANSS: (a) less than 5 on G8 (uncooperativeness), P1 (delusions), P3 (hallucinations), P4 (excitement/hyperactivity), and P6 (suspiciousness/persecution); (b) less than 4 on P7 (hostility), and G14 (poor impulse control) Has an informant who is considered reliable by the Investigator Body mass index (BMI) between 18-40 kg/m2 inclusive Female participants are eligible to participate if not pregnant, not breastfeeding and agree to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 28 days after the last dose of study drug Exclusion Criteria: Moderate to severe substance use disorder within six months of study entry (excluding nicotine or caffeine) as defined by DSM-5 Extrapyramidal symptom rating scale (ESRS-A CGI) subscore greater than or equal to 3 Other current DSM-5 diagnosis (e.g., bipolar disorder, major depressive disorder) PANSS item G6 (depression) greater than or equal to 5 Significant risk of suicide or harming him- or herself or others according to the Investigator's judgment A prior or current general medical condition that might be impairing cognition or other psychiatric functioning Positive result at screening for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or HIV-1 and HIV-2. HCV antibody positive participants are eligible if HCV RNA is negative Tardive dyskinesia that is moderate to severe or requires treatment History of neuroleptic malignant syndrome Average triplicate Fridericia's Correction Formula (QTcF) interval greater than 450 milliseconds (msec) for males and 470 msec for females or other clinically significant abnormality on screening electrocardiogram (ECG) based on centralized reading Clinically significant abnormalities in laboratory safety test results Significant or unstable physical condition that in the investigator's judgment might require a change in medication or hospitalization during the course of the study On more than one antidepressant, or if on one antidepressant, a change in dose within 28 days prior to screening History of clozapine treatment History of treatment with electroconvulsive therapy (ECT) Concomitant use of prohibited medications Positive urine drug screen for amphetamines, methamphetamines, opiates, buprenomorphine, methadone, cannabinoids, cocaine, and barbiturates Receipt of an investigational drug within 28 days or five times the half-life of the investigational drug (whichever is longer) before the first study drug administration Donation of blood over 400 mL within 3 months prior to screening Diagnosis of COVID-19 infection (confirmed or presumptive) 4 weeks prior to screening or during screening. Participants can be re-screened after 4 weeks of full recovery in addition to Investigator and/or institutional approval to enroll

Contacts/Locations


Study Officials:	Clinical Trials Study Director Hoffmann-La Roche
Locations:	United States, California
	CITrials, Inc. Bellflower, California, United States, 90706
	CITrials - Santa Ana Costa Mesa, California, United States, 92626
	Collaborative Neuroscience Network, Inc. Garden Grove, California, United States, 92845
	California Clinical Trials Glendale, California, United States, 91206
	Synergy San Diego Lemon Grove, California, United States, 91945
	Catalina Research Institute LLC - MRA Montclair, California, United States, 91763
	ASCLEPES Research Centers Panorama City, California, United States, 91402
	CITrials, Inc. Riverside, California, United States, 92506
	California Neuropsychopharmacology Clinical Research Institute, LLC San Diego, California, United States, 92102
	Stanford University School of Medicine Stanford, California, United States, 94305
	Collaborative Neuroscience Network Inc. Torrance, California, United States, 90502
	United States, Connecticut
	Yale School of Medicine - CT Mental Health Center (CMHC) - Schizophrenia Research Clinic New Haven, Connecticut, United States, 06519
	United States, Florida
	Innovative Clinical Research, Inc. Lauderhill, Florida, United States, 33319
	Lifestream Behavioral Center Leesburg, Florida, United States, 34748
	Accel Research Sites - Maitland - ERN - PPDS Maitland, Florida, United States, 32751
	Premier Clinical Research Institute - Miami - BTC - PPDS Miami, Florida, United States, 33122
	Advanced Research Institute of Miami Miami, Florida, United States, 33135
	Health Synergy Clinical Research Okeechobee, Florida, United States, 34972
	United States, Georgia
	Emory University Atlanta, Georgia, United States, 30329
	United States, Illinois
	Northwestern University Chicago, Illinois, United States, 60611-2987
	United States, Maryland
	CBH Health Gaithersburg, Maryland, United States, 20877
	United States, Michigan
	Michigan Clinical Research Institute PC - Clinedge - PPDS Ann Arbor, Michigan, United States, 48105
	United States, Mississippi
	Precise Research Centers Flowood, Mississippi, United States, 39232
	United States, Missouri
	Psych Care Consultants Research Saint Louis, Missouri, United States, 63128
	Millennium Psychiatric Associates, LLC Saint Louis, Missouri, United States, 63132
	United States, New York
	New York State Psychiatric Institute New York, New York, United States, 10032
	Manhattan Psychiatric Center; Psychopharmacology Research Unit New York, New York, United States, 10035
	United States, Texas
	JPS Health Network Fort Worth, Texas, United States, 76104
	Pillar Clinical Research LLC Garland, Texas, United States, 75042
	Baylor College of Medicine Houston, Texas, United States, 77030
	University Hills Clinical Research Irving, Texas, United States, 75062
	The Solace Center Missouri City, Texas, United States, 77459
	Psychiatry & Behavioral Center Richmond, Texas, United States, 77406
	@ Health Texas Richmond, Texas, United States, 77407
	Japan
	Kohnodai Hp., National Center for Global Health and Medicine Chiba, Japan, 272-8516
	National Hospital Organization Ryukyu Hospital Kunigami, Japan, 904-1201
	Nankokokorono Clinic Shirakawa, Japan, 961-0021
	National Center of Neurology and Psychiatry Tokyo, Japan, 187-8551
	Seishinkai Okehazama Hospital Fujita Kokoro Care Center Toyoake, Japan, 470-1168
	Hiyoshi Hospital Yokohama-shi, Japan, 223-0062
	Poland
	Centrum Zdrowia Psychicznego Biomed ? Jan Latala Kielce, Poland, 25-411
	Spain
	C.H. Regional Reina Sofia - PPDS Cordoba, Spain, 14004
	Hospital Universitario 12 De Octubre Madrid, Spain, 28041
	Hosp Univ Fundacion Alcorcon Madrid, Spain, 28922
	Hospital Regional Universitario de Malaga ? Hospital General Malaga, Spain, 29010
	Complejo Asistencial Universitario de Salamanca ? H. Clinico Salamanca, Spain, 37007
	Spain, Asturias
	Hospital Universitario Central de Asturias Oviedo, Asturias, Spain, 33011
	Spain, Barcelona
	Corporacio Sanitaria Parc Tauli Sabadell, Barcelona, Spain, 08208
	Spain, Cantabria
	Hospital Universitario Marques de Valdecilla Santander, Cantabria, Spain, 39008
	Ukraine, KIEV Governorate
	ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council Dnipro, KIEV Governorate, Ukraine, 49005
	Medical and diagnostic center Healthy and Happy of Limited Liability Company Healthy and Happy Kyiv, KIEV Governorate, Ukraine, 01033
	Zakarpattia Regional Clinical Hospital n.a. Andrii Novak Uzhhorod, KIEV Governorate, Ukraine, 88000
	Ukraine, Katerynoslav Governorate
	CNCE Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council Nove, Katerynoslav Governorate, Ukraine, 25491
	Ukraine, Kharkiv Governorate
	Communal Non-Commercial Enterprise of Kharkiv RC Regional clinical psychiatric hospital #3 Kharkiv, Kharkiv Governorate, Ukraine, 61068
	Ukraine, Kherson Governorate
	Public NPE Kherson Regional Institution of Mental Care of Kherson RC Kherson, Kherson Governorate, Ukraine, 73488
	Municipal Non-Commercial Enterprise Odesa RMC for Mental Health of Odessa Regional Council Odesa, Kherson Governorate, Ukraine, 65006
	Ukraine, Podolia Governorate
	Communal NPE Vinnytsia Reg. Clin. Psychoneurolog. Hosp. n.a. O.I. Yushchenko of Vinnytsia RC Vinnytsia, Podolia Governorate, Ukraine, 21037

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