Trial · NCT03588572
The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study
NCT03588572, Not applicable, Completed, Guangzhou General Hospital of Guangzhou Military Command; results first posted 2019-10-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study. Trials, record NCT03588572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03588572
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Venlafaxine on Language Function in Patients With Subcortical Aphasia: A fMRI Study
- NCT number
- NCT03588572
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 43 participants, actual
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Conditions
- Subcortical Aphasia, Ischemic Stroke
- Interventions
- Venlafaxine hydrochloride capsules
- First posted
- 2018-07-17
- Last updated
- 2021-10-13
- Results first posted
- 2019-10-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | 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. |
| Secondary | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | 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. |
| Secondary | A Change of Outcome Measure:Picture Naming Test(PNT) | 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. |
| Secondary | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | 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). |
| Secondary | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | 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). |
| Secondary | Follow-up Measurement: Mini-Mental State Examination (MMSE) | 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. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | 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. | score on a scale | MEAN | |
| SECONDARY | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | 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. | score on a scale | MEAN | |
| SECONDARY | A Change of Outcome Measure:Picture Naming Test(PNT) | 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. | score on a scale | MEAN | |
| SECONDARY | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | 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. | score on a scale | MEAN | |
| SECONDARY | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | 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. | score on a scale | MEAN | |
| SECONDARY | Follow-up Measurement: Mini-Mental State Examination (MMSE) | 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. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Venlafaxine Group | Visitation 1 | 78.16 | Standard Deviation 7.93 | score on a scale |
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Controlled Group | Visitation 1 | 78.60 | Standard Deviation 6.38 | score on a scale |
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Venlafaxine Group | Visitation 2 | 88.24 | Standard Deviation 6.15 | score on a scale |
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Controlled Group | Visitation 2 | 83.51 | Standard Deviation 5.37 | score on a scale |
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Venlafaxine Group | Visitation 3 | 94.23 | Standard Deviation 4.38 | score on a scale |
| A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Controlled Group | Visitation 3 | 88.55 | Standard Deviation 3.95 | score on a scale |
| A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Venlafaxine Group | Visitation 1 | 5.31 | Standard Deviation 1.99 | score on a scale |
| A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Controlled Group | Visitation 1 | 5.75 | Standard Deviation 1.81 | score on a scale |
| A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Venlafaxine Group | Visitation 2 | 9.31 | Standard Deviation 1.54 | score on a scale |
| A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Controlled Group | Visitation 2 | 8.13 | Standard Deviation 1.5 | score on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Visitation 1 | STARTED | Venlafaxine Group | 22 | |
| Visitation 1 | STARTED | Controlled Group | 21 | |
| Visitation 1 | COMPLETED | Venlafaxine Group | 21 | |
| Visitation 1 | COMPLETED | Controlled Group | 20 | |
| Visitation 1 | NOT COMPLETED | Venlafaxine Group | 1 | |
| Visitation 1 | NOT COMPLETED | Controlled Group | 1 | |
| Visitation 2 | STARTED | Venlafaxine Group | 21 | |
| Visitation 2 | STARTED | Controlled Group | 20 | |
| Visitation 2 | COMPLETED | Venlafaxine Group | 19 | |
| Visitation 2 | COMPLETED | Controlled Group | 18 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Venlafaxine Group | 0 | 16 |
| Total, all-cause mortality | Controlled Group | 0 | 16 |
| Total, other adverse events | Venlafaxine Group | 0 | 16 |
| Total, other adverse events | Controlled Group | 0 | 16 |
| Total, serious adverse events | Venlafaxine Group | 0 | 16 |
| Total, serious adverse events | Controlled Group | 0 | 16 |
Source ClinicalTrials.gov
Papers31
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Venlafaxine Group vs Controlled Group: deaths from any cause | Trial comparisons |
| Venlafaxine Group vs Controlled Group: serious adverse events | Trial comparisons |
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Picture Naming Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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