A Study of CX157 (TriRima) for the Treatment of Depression (CX157-200)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

CeNeRx BioPharma Inc.

ClinicalTrials.gov Identifier:

NCT00739908

First received: August 20, 2008

Last updated: June 26, 2012

Last verified: June 2012

History of Changes

Results First Received: February 14, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Major Depressive Disorder
Interventions:	Drug: CX157 (TriRima) Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 14 out-patient medical centers in the United States (US) from 16 September 2008 (date of first subject randomized) to 09 July 2009 (last subject’s last visit).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 587 subjects were screened. Three hundred and two (302) subjects failed to meet study entry criteria, and thus were screen failures. The top three reasons for screen failure were: IDS-SR30 total score cut-off for randomization not met (204 pts); presence of cardiovascular abnormality (18 pts) and Laboratory Abnormalities (14 pts).

Reporting Groups

	Description
Oral CX157 60 mg TID (Total Daily Dose of 180 mg)	CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Oral Placebo TID	Placebo does not have any active medication and is the same as a Sugar Pill.

Participant Flow: Overall Study

	Oral CX157 60 mg TID (Total Daily Dose of 180 mg)	Oral Placebo TID
STARTED	142	143
COMPLETED	117	118
NOT COMPLETED	25	25
Adverse Event	5	6
Withdrawal by Subject	4	2
Lost to Follow-up	14	9
Non-Compliance With Study Procedures	2	3
Non-Compliance With Study Medication	0	3
Lack of Efficacy	0	1
Relocation	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Oral CX157 60 mg TID (Total Daily Dose of 180 mg)	CX157 is an investigational compound. The mechanism of action of this compound is Reversible Monoamine oxidase inhibition (MAOI)
Oral Placebo TID	Placebo does not have any active medication and is the same as a Sugar Pill.
Total	Total of all reporting groups

Baseline Measures

	Oral CX157 60 mg TID (Total Daily Dose of 180 mg)	Oral Placebo TID	Total
Number of Participants [units: participants]	142	143	285
Age [units: participants]
<=18 years	0	5	5
Between 18 and 65 years	142	138	280
>=65 years	0	0	0
Age [units: years] Mean (Standard Deviation)	39.1 (11.14)	38.5 (11.16)	38.8 (11.14)
Gender [units: participants]
Female	80	81	161
Male	62	62	124
Race (NIH/OMB) [units: Participants]
American Indian or Alaska Native	3	2	5
Asian	3	2	5
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	30	32	62
White	102	105	207
More than one race	0	0	0
Unknown or Not Reported	4	2	6
Region of Enrollment [units: participants]
United States	142	143	285

Outcome Measures

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1. Primary:

Change From Randomization in Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: Randomization and study end (Week 6). ]

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2. Secondary:

Montgomery and Asberg Depression Rating Scale (MADRS) Response Rate [ Time Frame: Week 6 or the last available post treatment result (LOCF) ]

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3. Secondary:

Montgomery and Asberg Depression Rating Scale (MADRS) Remitter Rate [ Time Frame: Week 6 or the last available post treatment result (LOCF) ]

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4. Secondary:

The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Randomization and Week 6 or the last available post treatment result (LOCF) ]

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5. Secondary:

Inventory of Depressive Symptomatology 30 Item -Self Report (IDS -SR 30 Items) [ Time Frame: Randomization and Week 6 or the last available post treatment result (LOCF) ]

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6. Secondary:

Clinical Global Impression - Improvement of Illness (CGI-I) [ Time Frame: Week 6 or the last available post treatment result (LOCF) ]

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7. Secondary:

Clinical Global Impression - Severity of Illness (CGI-S) [ Time Frame: Week 6 or the last available post treatment result (LOCF) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Subjects were asked to take 6 capsules 3 times a day for 6 weeks. Non-adherence with the study medication was high based on the population PK data. This likely contributed to the results in CX157 treatment group.

More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigators were informed that the first publication or disclosure of study results shall be a complete, joint multicenter publication or disclosure coordinated by CeNeRx. Thereafter, any secondary publications will reference the original publication(s).

Results Point of Contact:

Name/Title: Mahnaz Asgharnejad, Pharm.D.; Daniel Burch, M.D.
Organization: CeNeRx BioPharma Inc.
phone: (919) 655 1435; (919) 674 6041
e-mail: masgharnejad@cenerx.com; danburch@cenerx.com

Responsible Party:	CeNeRx BioPharma Inc.
ClinicalTrials.gov Identifier:	NCT00739908 History of Changes
Other Study ID Numbers:	CX157-200
Study First Received:	August 20, 2008
Results First Received:	February 14, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

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