Study Comparing the Efficacy of Venlafaxine XR Vs. SSRIs and Conventional Antidepressants in Depressed Patients

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00474708
• Collaborator: (none)
• Enrollment: 1,151
• Locations: 26
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 44.3
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

This study is an open-label, randomized, multi-center study conducted in a typical psychiatric outpatient practice in China. This study is intended to collect data on the efficacy and safety of venlafaxine XR (Efexor XR®) versus SSRIs and conventional antidepressants in depressed patients that previously failed antidepressant treatment. This data will be used to guide psychiatrists on recommendations for clinic use.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Effexor; Drug: SSRI	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Efficacy of Venlafaxine XR (Efexor XR®) Versus SSRIs & Conventional Antidepressants in Depressed Patients Switched From Prior Antidepressants in Psychiatric Outpatient Care Settings in China
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 1.Effexor XR Group	Drug: Effexor
Active Comparator: 2 2.SSRI or Conventional Antidepressant Group	Drug: SSRI

Outcome Measures

Primary Outcome Measures

1. Number of Patients Achieving Remission [12 weeks]

   Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.

Secondary Outcome Measures

1. Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status) [12 weeks]

   Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Inclusion Criteria:

• Males or females, 18 -65 years of age

• Outpatients

• Major depressive disorder based on DSM-IV criteria

• The baseline score of 17-item HAM-D³17

• Switchers from prior antidepressants, who have had no satisfactory improvement (normally after a minimum of 8weeks of treatment), with an approved antidepressant medication or have experienced intolerance due to side effects to their antidepressant medication based on clinical discretion

• Provide written informed consent

• If female is of childbearing potential, must be confirmed no pregnancy at baseline, and use a medically acceptable method of contraception throughout the study.

Main Exclusion Criteria:

• Hypersensitivity to venlafaxine;

• Clinically significant renal or hepatic disease or any other medical disease that, in the opinion of the investigator, might compromise the study, including seizure

• Alcohol or drug abuse within the last year

• A recent history of myocardial infarction or unstable heart disease (within 6 months of baseline)

• Bipolar disorder

• For female, known or suspected pregnancy or breast feeding

• Use of a monoamine oxidase inhibitor (MAOI) within 14 days of baseline; use of any investigational drug within 30 days of baseline.

• Patients have prior use of venlafaxine or use of venlafaxine for the current episode.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beijing	Beijing	China	100080
2		Beijing	Beijing	China	100083
3		Beijing	Beijing	China	100096
4		Guangzhou	Guangdong	China	510000
5		Guangzhou	Guangdong	China	510080
6		Guangzhou	Guangdong	China	510150
7		Guangzhou	Guangdong	China	510370
8		Zhengzhou	Henan	China	450006
9		Wuhan	Hubei	China	430022
10		Changsha	Hunan	China	410011
11		Nanjing	Jiangsu	China	210029
12		Shenyang	Liaoning	China	110168
13		Jinan	Shandong	China	250014
14		Shanghai	Shanghai	China	200003
15		Shanghai	Shanghai	China	200030
16		Shanghai	Shanghai	China	200080
17		Shanghai	Shanghai	China	200083
18		Shanghai	Shanghai	China	200090
19		Shanghai	Shanghai	China	200124
20		Shanghai	Shanghai	China	201900
21		Xian	Shanxi	China	710061
22		Tianjin	Tianjin	China	300350
23		Hangzhou	Zhejiang	China	310000
24		Hangzhou	Zhejiang	China	310013
25		Huzhou	Zhejiang	China	313000
26		Suzhou	Zhejiang	China	215008

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• ClinicalTrials.gov Identifier: NCT00474708
• Other Study ID Numbers: 0600B2-4418
• First Posted: May 17, 2007
• Last Update Posted: Mar 5, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Depressive Disorder; Depressive Disorder, Major; Venlafaxine Hydrochloride

Study Results

Participant Flow

Recruitment Details	Participants were recruited in China from March 2007 to January 2008.
Pre-assignment Detail	There was no screening period for this study. Screening was done by the investigator.

Arm/Group Title	Venlafaxine XR	SSRI or Conventional Antidepressant Group
Arm/Group Description	75-225 mg per day	Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
Period Title: Overall Study
STARTED	791	367
COMPLETED	734	342
NOT COMPLETED	57	25

Baseline Characteristics

Arm/Group Title	Venlafaxine XR	SSRI or Conventional Antidepressant Group	Total
Arm/Group Description	75-225 mg per day	Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.	Total of all reporting groups
Overall Participants	787	364	1151
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	39.97 (12.84)	40.49 (13.08)	40.13 (12.92)
Sex: Female, Male (Count of Participants)
Female	460 58.4%	225 61.8%	685.0 59.5%
Male	327 41.6%	139 38.2%	466.0 40.5%

Outcome Measures

1. Primary Outcome

Title	Number of Patients Achieving Remission
Description	Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment.

Arm/Group Title	Venlafaxine XR	SSRI or Conventional Antidepressant Group
Arm/Group Description	75-225 mg per day	Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
Measure Participants	664	295
Number [participants]	554 70.4%	207 56.9%

2. Secondary Outcome

Title	Number of Patients Achieving Remission (by Co-morbid Anxiety Disorder Status)
Description	Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most sever) for a maximum total score of 50.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The analysis population is the per protocol population, consisting of patients who have received at least one dose and have completed the 12 week clinical assessment. A total of 125 (VEN XR=83, SSRI=42) patients had a co-morbid anxiety disorder and 834 (VEN XR=581, SSRI=253) did not.

Arm/Group Title	Venlafaxine XR	SSRI or Conventional Antidepressant Group
Arm/Group Description	75-225 mg per day	Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
Measure Participants	664	295
Co-morbid anxiety disorder	60 7.6%	23 6.3%
No anxiety disorder	494 62.8%	184 50.5%

Adverse Events

Arm/Group Title	Venlafaxine XR		SSRI or Conventional Antidepressant Group
Arm/Group Description	75-225 mg per day		Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
All Cause Mortality
	Venlafaxine XR		SSRI or Conventional Antidepressant Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Venlafaxine XR		SSRI or Conventional Antidepressant Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/ (NaN)		1/ (NaN)
Psychiatric disorders
Attempted suicide	1/787 (0.1%)		0/365 (0%)
Hospitalization	1/787 (0.1%)		1/365 (0.3%)
Reproductive system and breast disorders
Pregnancy	1/787 (0.1%)		0/365 (0%)
Other (Not Including Serious) Adverse Events
	Venlafaxine XR		SSRI or Conventional Antidepressant Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	418/ (NaN)		236/ (NaN)
Blood and lymphatic system disorders
Leucopenia	2/787 (0.3%)		7/365 (1.9%)
Cardiac disorders
Hypertension	3/787 (0.4%)		1/365 (0.3%)
Tachycardia	0/787 (0%)		1/365 (0.3%)
Palpitations	12/787 (1.5%)		5/365 (1.4%)
Unstable blood pressure	1/787 (0.1%)		0/365 (0%)
Ear and labyrinth disorders
Tinnitus	1/787 (0.1%)		2/365 (0.5%)
Eye disorders
Visual abnormal	3/787 (0.4%)		0/365 (0%)
Eye disorder	2/787 (0.3%)		0/365 (0%)
Dry eye	2/787 (0.3%)		0/365 (0%)
Gastrointestinal disorders
Constipation	66/787 (8.4%)		43/365 (11.8%)
Irritable bowel syndrome	1/787 (0.1%)		0/365 (0%)
Nausea	65/787 (8.3%)		47/365 (12.9%)
Diarrhea	7/787 (0.9%)		6/365 (1.6%)
Dry mouth	48/787 (6.1%)		24/365 (6.6%)
Bitter taste	3/787 (0.4%)		0/365 (0%)
No appetite	2/787 (0.3%)		4/365 (1.1%)
Vomiting	8/787 (1%)		2/365 (0.5%)
Stomach disorder	4/787 (0.5%)		1/365 (0.3%)
Gastrointestinal disorder	2/787 (0.3%)		6/365 (1.6%)
Gastrointestinal reaction	3/787 (0.4%)		0/365 (0%)
Flatulence	7/787 (0.9%)		7/365 (1.9%)
Stomach ache	0/787 (0%)		1/365 (0.3%)
Dyspepsia	2/787 (0.3%)		0/365 (0%)
Anorexia	4/787 (0.5%)		5/365 (1.4%)
General disorders
Fever	1/787 (0.1%)		0/365 (0%)
Feeble	7/787 (0.9%)		1/365 (0.3%)
Abdominal disorder	1/787 (0.1%)		0/365 (0%)
Muscular soreness	0/787 (0%)		1/365 (0.3%)
Fatigue	10/787 (1.3%)		3/365 (0.8%)
General malaise	1/787 (0.1%)		0/365 (0%)
Head malaise	2/787 (0.3%)		0/365 (0%)
Headache	21/787 (2.7%)		0/365 (0%)
Chest pain	1/787 (0.1%)		0/365 (0%)
Waist disorder	1/787 (0.1%)		0/365 (0%)
Hepatobiliary disorders
Hepatic function abnormal	4/787 (0.5%)		4/365 (1.1%)
Metabolism and nutrition disorders
Hyperlipaemia	4/787 (0.5%)		2/365 (0.5%)
Thirst	0/787 (0%)		1/365 (0.3%)
Weight increase	1/787 (0.1%)		6/365 (1.6%)
Weight decrease	5/787 (0.6%)		0/365 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/787 (0%)		2/365 (0.5%)
Muscel spasm	1/787 (0.1%)		0/365 (0%)
Waist pain	2/787 (0.3%)		0/365 (0%)
Nervous system disorders
Anesthesia local	1/787 (0.1%)		0/365 (0%)
Dizziness	40/787 (5.1%)		13/365 (3.6%)
Vertigo	2/787 (0.3%)		0/365 (0%)
Tremor	2/787 (0.3%)		1/365 (0.3%)
Night sweats	3/787 (0.4%)		0/365 (0%)
Sweating increased	10/787 (1.3%)		7/365 (1.9%)
Psychiatric disorders
Sluggish	1/787 (0.1%)		0/365 (0%)
Dreaminess	1/787 (0.1%)		0/365 (0%)
Fidget	1/787 (0.1%)		1/365 (0.3%)
Anxiety	2/787 (0.3%)		7/365 (1.9%)
Insomina	7/787 (0.9%)		8/365 (2.2%)
Somnolence	6/787 (0.8%)		3/365 (0.8%)
Sleep disorder	0/787 (0%)		1/365 (0.3%)
Sexual dysfunction	1/787 (0.1%)		2/365 (0.5%)
Sexual hypoesthesia	2/787 (0.3%)		7/365 (1.9%)
Drug abuse	1/787 (0.1%)		0/365 (0%)
Irritability	1/787 (0.1%)		0/365 (0%)
Manic	1/787 (0.1%)		0/365 (0%)
Switching	1/787 (0.1%)		2/365 (0.5%)
Suicide	1/787 (0.1%)		0/365 (0%)
Dreaming abnormal	1/787 (0.1%)		0/365 (0%)
Renal and urinary disorders
Micturition frequency	3/787 (0.4%)		0/365 (0%)
Dysuria	2/787 (0.3%)		1/365 (0.3%)
Micturition disorder	1/787 (0.1%)		0/365 (0%)
Reproductive system and breast disorders
Amenorrhoea	4/787 (0.5%)		0/365 (0%)
Pregnancy	1/787 (0.1%)		0/365 (0%)
Oligiomenorrhea	2/787 (0.3%)		0/365 (0%)
Menstrual disorder	1/787 (0.1%)		0/365 (0%)
Ejaculation disorder	2/787 (0.3%)		1/365 (0.3%)
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection	3/787 (0.4%)		0/365 (0%)
Skin and subcutaneous tissue disorders
Pruritus	4/787 (0.5%)		0/365 (0%)

Limitations/Caveats

365 participants were assessed for safety. Certain demographic data (gender and age) is missing for one participant. Thereby resulting in the participant flow reflecting 364 participants.

More Information

Certain Agreements

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

The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.