Trial Outcomes & Findings for Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program (NCT NCT00401726)

Last Updated: 2012-04-23

Results Overview

Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). "Very satisfied" was defined as a score of greater than or equal to 8.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

537 participants

Primary outcome timeframe

112 days

Results posted on

2012-04-23

Participant Flow

Subjects were recruited in the United States from June 2006 to March 2007.

Subjects were enrolled according to the inclusion / exclusion criteria. There was not a screening period.

Participant milestones

Participant milestones
Measure	Venlafaxine Extended Release (ER) 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Overall Study STARTED	269	268
Overall Study COMPLETED	172	156
Overall Study NOT COMPLETED	97	112

Reasons for withdrawal

Reasons for withdrawal
Measure	Venlafaxine Extended Release (ER) 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Overall Study Adverse Event	34	45
Overall Study Death	0	3
Overall Study Sponsor Request	0	1
Overall Study Physician Decision	3	6
Overall Study Lost to Follow-up	23	20
Overall Study Protocol Violation	6	3
Overall Study Withdrawal by Subject	18	24
Overall Study Lack of Efficacy	4	6
Overall Study Protocol Deviation	9	4

Baseline Characteristics

Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venlafaxine Extended Release (ER) n=269 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=268 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.	Total n=537 Participants Total of all reporting groups
Age Continuous	44.13 years STANDARD_DEVIATION 13.59 • n=5 Participants	45.25 years STANDARD_DEVIATION 13.83 • n=7 Participants	44.69 years STANDARD_DEVIATION 13.71 • n=5 Participants
Sex: Female, Male Female	199 Participants n=5 Participants	190 Participants n=7 Participants	389 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	78 Participants n=7 Participants	148 Participants n=5 Participants

PRIMARY outcome

Timeframe: 112 days

Population: The analysis population was the Modified Intent to Treat population, which included all patients who received a prescription and had at least 1 post-baseline efficacy evaluation; last observation carried forward.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)	160 participants	138 participants

SECONDARY outcome

Timeframe: Baseline and 112 days

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks	-10.87 units on scale Standard Error 0.39	-11.03 units on scale Standard Error 0.40

SECONDARY outcome

Timeframe: 112 days

PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Patient Global Impression of Improvement (PGI-I) Score	2.33 units on scale Standard Error 0.08	2.51 units on scale Standard Error 0.09

SECONDARY outcome

Timeframe: Baseline and 112 days

WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks	6.86 units on scale Standard Error 0.35	6.97 units on scale Standard Error 0.36

SECONDARY outcome

Timeframe: 112 days

Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of "Never miss" or "Sometimes miss".

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Number of Patients Compliant With Therapy	248 participants	232 participants

SECONDARY outcome

Timeframe: Baseline and 112 days

IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks	-17.75 units on scale Standard Error 0.71	-17.50 units on scale Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline and 112 days

The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=254 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Change in Sheehan Disability Scale Score From Baseline to 16 Weeks	-7.99 units on scale Standard Error 0.45	-6.99 units on scale Standard Error 0.47

SECONDARY outcome

Timeframe: 112 days

CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).

Outcome measures

Outcome measures
Measure	Venlafaxine Extended Release (ER) n=253 Participants 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=239 Participants Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 1 (very much improved)	82 patients	81 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 2 (much improved)	84 patients	75 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 3 (improved)	50 patients	49 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 4 (no change)	24 patients	21 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 5 (worse)	11 patients	8 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 6 (much worse)	2 patients	5 patients
Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks CGI - 7 (very much worse)	0 patients	0 patients

Adverse Events

Venlafaxine Extended Release (ER)

Serious events: 10 serious events

Other events: 209 other events

Deaths: 0 deaths

Venlafaxine Extended Release (ER) Plus Dialogues

Serious events: 18 serious events

Other events: 214 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Venlafaxine Extended Release (ER) n=269 participants at risk 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=268 participants at risk Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
Injury, poisoning and procedural complications Accidental Injury	0.37% 1/269	0.37% 1/268
Cardiac disorders Angina Pectoris	0.00% 0/269	0.37% 1/268
Respiratory, thoracic and mediastinal disorders Asthma	0.37% 1/269	0.00% 0/268
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma of lung	0.00% 0/269	0.37% 1/268
Vascular disorders Cerebrovascular Accident	0.37% 1/269	0.37% 1/268
Cardiac disorders Chest pain	0.00% 0/269	0.37% 1/268
Hepatobiliary disorders Cholecystits	0.37% 1/269	0.00% 0/268
Renal and urinary disorders Cholelithiasis	0.00% 0/269	0.37% 1/268
Cardiac disorders Coronary Artery Disorder	0.00% 0/269	0.75% 2/268
Psychiatric disorders Depression	0.37% 1/269	0.00% 0/268
General disorders Drug Abuse	0.00% 0/269	0.37% 1/268
General disorders Hernia	0.37% 1/269	0.00% 0/268
Cardiac disorders Hypertension	0.00% 0/269	0.37% 1/268
Vascular disorders Intracranial Hemorrhage	0.00% 0/269	0.37% 1/268
Gastrointestinal disorders Nausea	0.00% 0/269	0.37% 1/268
Psychiatric disorders Neurosis	0.37% 1/269	0.00% 0/268
General disorders Non-specific Drug Reaction	0.00% 0/269	0.37% 1/268
General disorders Overdose	0.00% 0/269	0.37% 1/268
Respiratory, thoracic and mediastinal disorders Pneumonia	0.37% 1/269	0.00% 0/268
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.37% 1/269	0.00% 0/268
General disorders Self-injurious Ideation	0.00% 0/269	0.37% 1/268
Psychiatric disorders Suicidal Ideation	0.37% 1/269	0.75% 2/268
Psychiatric disorders Suicide	0.00% 0/269	0.37% 1/268
Psychiatric disorders Suicide Attempt	0.00% 0/269	0.75% 2/268
Cardiac disorders Supraventricular Tachycardia	0.37% 1/269	0.00% 0/268
Psychiatric disorders Thinking Abnormal	0.00% 0/269	0.75% 2/268
Pregnancy, puerperium and perinatal conditions Unintended Pregnancy	0.37% 1/269	0.00% 0/268
Gastrointestinal disorders Vomiting	0.00% 0/269	0.37% 1/268

Other adverse events

Other adverse events
Measure	Venlafaxine Extended Release (ER) n=269 participants at risk 75-225 mg per day	Venlafaxine Extended Release (ER) Plus Dialogues n=268 participants at risk Venlafaxine ER 75-225 mg per day plus "Dialogues Time to Talk" program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
General disorders Asthenia	5.2% 14/269	7.1% 19/268
General disorders Headache	11.2% 30/269	7.5% 20/268
General disorders Infection	6.3% 17/269	4.5% 12/268
Cardiac disorders Cardiovascular general	10.4% 28/269	10.1% 27/268
Gastrointestinal disorders Constipation	4.1% 11/269	12.7% 34/268
Gastrointestinal disorders Diarrhea	3.0% 8/269	5.6% 15/268
Gastrointestinal disorders Dry mouth	4.1% 11/269	6.3% 17/268
Gastrointestinal disorders Nausea	10.0% 27/269	15.7% 42/268
Metabolism and nutrition disorders Metabolic and nutritional general	3.3% 9/269	5.6% 15/268
Musculoskeletal and connective tissue disorders Musculoskeletal general	3.3% 9/269	5.6% 15/268
Nervous system disorders Dizziness	6.3% 17/269	7.5% 20/268
Nervous system disorders Insomnia	13.4% 36/269	14.2% 38/268
Nervous system disorders Somnolence	6.3% 17/269	6.3% 17/268
Respiratory, thoracic and mediastinal disorders Respiratory general	16.7% 45/269	16.0% 43/268
Skin and subcutaneous tissue disorders Skin and appendages general	8.6% 23/269	10.1% 27/268
Eye disorders Special senses general	5.2% 14/269	4.5% 12/268
Renal and urinary disorders Urogenital general	10.4% 28/269	9.3% 25/268

Additional Information

U. S. Contact Center

Wyeth

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER