Trial Outcomes & Findings for The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study (NCT NCT03588572)
NCT ID: NCT03588572
Last Updated: 2021-10-13
Results Overview
The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ\<93.8 can be judged as language dysfunction.
COMPLETED
NA
43 participants
This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.
2021-10-13
Participant Flow
Participant milestones
| Measure |
Venlafaxine Group
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
Visitation 1
STARTED
|
22
|
21
|
|
Visitation 1
COMPLETED
|
21
|
20
|
|
Visitation 1
NOT COMPLETED
|
1
|
1
|
|
Visitation 2
STARTED
|
21
|
20
|
|
Visitation 2
COMPLETED
|
19
|
18
|
|
Visitation 2
NOT COMPLETED
|
2
|
2
|
|
Visitation 3
STARTED
|
19
|
18
|
|
Visitation 3
COMPLETED
|
16
|
16
|
|
Visitation 3
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Venlafaxine Group
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
Visitation 1
Lack of Efficacy
|
1
|
1
|
|
Visitation 2
Lost to Follow-up
|
1
|
1
|
|
Visitation 2
Lack of Efficacy
|
0
|
1
|
|
Visitation 2
Withdrawal by Subject
|
1
|
0
|
|
Visitation 3
Lost to Follow-up
|
1
|
1
|
|
Visitation 3
Physician Decision
|
1
|
1
|
|
Visitation 3
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
55.19 years
STANDARD_DEVIATION 10.94 • n=16 Participants
|
54.06 years
STANDARD_DEVIATION 9.00 • n=16 Participants
|
54.62 years
STANDARD_DEVIATION 9.42 • n=32 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=16 Participants
|
5 Participants
n=16 Participants
|
12 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=16 Participants
|
11 Participants
n=16 Participants
|
20 Participants
n=32 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
16 participants
n=16 Participants
|
16 participants
n=16 Participants
|
32 participants
n=32 Participants
|
|
Body Mass Index（BMI）
|
23.28 kg/m^2
STANDARD_DEVIATION 1.20 • n=16 Participants
|
23.15 kg/m^2
STANDARD_DEVIATION 1.31 • n=16 Participants
|
23.22 kg/m^2
STANDARD_DEVIATION 1.24 • n=32 Participants
|
|
Education Level
|
8.63 years
STANDARD_DEVIATION 3.07 • n=16 Participants
|
8.44 years
STANDARD_DEVIATION 2.25 • n=16 Participants
|
8.54 years
STANDARD_DEVIATION 2.77 • n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Hypertension · Yes
|
12 Participants
n=16 Participants
|
13 Participants
n=16 Participants
|
25 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Hypertension · No
|
4 Participants
n=16 Participants
|
3 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Diabetes · Yes
|
3 Participants
n=16 Participants
|
4 Participants
n=16 Participants
|
7 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Diabetes · No
|
13 Participants
n=16 Participants
|
12 Participants
n=16 Participants
|
25 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Hyperlipidemia · Yes
|
7 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
15 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Hyperlipidemia · No
|
9 Participants
n=16 Participants
|
8 Participants
n=16 Participants
|
17 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Smoking · Yes
|
6 Participants
n=16 Participants
|
7 Participants
n=16 Participants
|
13 Participants
n=32 Participants
|
|
Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking）
Smoking · No
|
10 Participants
n=16 Participants
|
9 Participants
n=16 Participants
|
19 Participants
n=32 Participants
|
PRIMARY outcome
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.The main outcome measure for this scale is Aphasia Quotient(AQ) which mainly tests the ability of spontaneous speech, oral comprehension, repetition, and naming, and reflects the severity of aphasia, and can be used as a reliable indicator to evaluate the improvement and deterioration of aphasia. Score fluctuation is 0-100 points, the normal value is 98.4-100 points, AQ\<93.8 can be judged as language dysfunction.
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)
Visitation 1
|
78.16 score on a scale
Standard Deviation 7.93
|
78.60 score on a scale
Standard Deviation 6.38
|
|
A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)
Visitation 2
|
88.24 score on a scale
Standard Deviation 6.15
|
83.51 score on a scale
Standard Deviation 5.37
|
|
A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)
Visitation 3
|
94.23 score on a scale
Standard Deviation 4.38
|
88.55 score on a scale
Standard Deviation 3.95
|
SECONDARY outcome
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.This test mainly assesses spontaneous speech fluency of participants.It requires participants name as many food names as possible within one minute, and each correct one to give one point.The higher the score, the better the language function.
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)
Visitation 1
|
5.31 score on a scale
Standard Deviation 1.99
|
5.75 score on a scale
Standard Deviation 1.81
|
|
A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)
Visitation 2
|
9.31 score on a scale
Standard Deviation 1.54
|
8.13 score on a scale
Standard Deviation 1.5
|
|
A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)
Visitation 3
|
12.69 score on a scale
Standard Deviation 1.49
|
10.81 score on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: This is an outcome measure to assess the improvement of language function from onset to 3 months after treatment. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.This test mainly assesses the ability of picture name of participants.we used a program for displaying named pictures on a computer screen (60 photos in total, of which 20 were Chinese celebrity faces). Each image was displayed in 3 seconds, and 1 point was correctly named for an image.The faces of celebrities were selected from the picture database of Chinese celebrities in the State Key Laboratory of Cognitive Neuroscience and Learning at Beijing Normal University.Score fluctuation is 0-60 points, the higher the score, the better the ability of picture name.
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
A Change of Outcome Measure:Picture Naming Test(PNT)
Visitation 1
|
39.19 score on a scale
Standard Deviation 5.19
|
38.31 score on a scale
Standard Deviation 5.23
|
|
A Change of Outcome Measure:Picture Naming Test(PNT)
Visitation 2
|
46.75 score on a scale
Standard Deviation 4.36
|
43.31 score on a scale
Standard Deviation 4.45
|
|
A Change of Outcome Measure:Picture Naming Test(PNT)
Visitation 3
|
52.25 score on a scale
Standard Deviation 2.6
|
48.31 score on a scale
Standard Deviation 3.96
|
SECONDARY outcome
Timeframe: We must determine that the participant is not in depression at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.The Hamilton Depression Rating Scale (HAMD) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine items are scored from 0-2. HAMD Scoring Instructions:0-7=Normal, 8-13 = Mild Depression, 14-18 = Moderate Depression, 19-22 = Severe Depression, ≥ 23 = Very Severe Depression(i.e.,Minimum 0 points and maximum 50 points, the higher the score, the greater the likelihood of depression).
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)
Visitation 1
|
5.63 score on a scale
Standard Deviation 0.96
|
5.25 score on a scale
Standard Deviation 0.93
|
|
Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)
Visitation 2
|
4.94 score on a scale
Standard Deviation 0.57
|
4.63 score on a scale
Standard Deviation 0.81
|
|
Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)
Visitation 3
|
4.06 score on a scale
Standard Deviation 0.93
|
3.88 score on a scale
Standard Deviation 0.72
|
SECONDARY outcome
Timeframe: We must determine that the participant is not in anxiety at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.The Hamilton Anxiety Rating Scale (HAMA) is a widely used and well-validated tool for measuring the severity of a patient's anxiety. The HAMA is composed of 14 items and takes 15-20 minutes to complete the interview and score the results. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe.HAMA Scoring Instructions:0-8=Normal, 8-13= Possible Anxiety, 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety(i.e.,the higher the score, the greater the likelihood of anxiety).
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)
Visitation 1
|
4.88 score on a scale
Standard Deviation 0.89
|
4.63 score on a scale
Standard Deviation 1.09
|
|
Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)
Visitation 2
|
4.13 score on a scale
Standard Deviation 0.96
|
4.00 score on a scale
Standard Deviation 0.73
|
|
Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)
Visitation 3
|
3.56 score on a scale
Standard Deviation 0.89
|
3.25 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: We must determine that the participant is not in moderate or more cognitive impairment at each follow-up. Thus, participates will undergo this assessment on the first days (V1), 28±3 days (V2), and 90±3 days (V3) after randomization.The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. Administration of the test takes between 5 and 10 minutes. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating lists of words, arithmetic such as the serial sevens, language use and comprehension, and basic motor skills. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.The raw score may also need to be corrected for educational attainment and age.
Outcome measures
| Measure |
Venlafaxine Group
n=16 Participants
The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation ( each containing venlafaxine 75mg), 1 capsule per day, until 4 weeks after randomization.
Venlafaxine hydrochloride capsules: The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
|
Controlled Group
n=16 Participants
the patients in controlled group do not use the drug during the experiment, and the other treatments are same as the venlafaxine group.
|
|---|---|---|
|
Follow-up Measurement: Mini-Mental State Examination (MMSE)
Visitation 1
|
23.81 score on a scale
Standard Deviation 1.22
|
23.88 score on a scale
Standard Deviation 1.15
|
|
Follow-up Measurement: Mini-Mental State Examination (MMSE)
Visitation 2
|
25.38 score on a scale
Standard Deviation 0.96
|
25.00 score on a scale
Standard Deviation 1.03
|
|
Follow-up Measurement: Mini-Mental State Examination (MMSE)
Visitation 3
|
26.38 score on a scale
Standard Deviation 0.81
|
26.19 score on a scale
Standard Deviation 0.83
|
Adverse Events
Venlafaxine Group
Controlled Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr.Yan Liu
Guangzhou General Hospital of Guangzhou Military Command
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place