Ischemic Stroke, Subcortical Aphasia
Conditions
Keywords
Behavioural evaluation, Functional magnetic resonance imaging, Venlafaxine
Brief summary
Previous studies have demonstrated that venlafaxine significantly improves the language function of healthy subjects and increase of fMRI activation in cortical language area. This study was designed to investigate the relationship between venlafaxine on the cortical language functional reorganization and clinical language improvements in the stroke patients with subcortical aphasia. It is a randomized, controlled, single-blind, longitudinal trial which has approved by the ethics committee of Guangzhou General Hospital of Guangzhou Military Command, and all patients and their guardian should sign an informed consent. The patients will divide into the venlafaxine group and the control group according to the principle of randomization (random number table). The patients in the venlafaxine group begin to take a venlafaxine hydrochloride capsule after enrollment ( each containing venlafaxine 75mg), qd, until 4 weeks after randomization, and the control group do not. Assessments of language functional behavior and examines of functional magnetic resonance imaging (fMRI) should be performed on the first days (V1), 28±3 days (V2) and 90±3 days (V3) after randomization. Through all this procession, we expect improve the language function of participants in experiment and clarify its mechanism,the research may help develop a new treatment for other patients with similar conditions.
Detailed description
The cases will recruit from inpatients with acute ischemic stroke in Department of Cerebrovascular disease, The Guangzhou General Hospital of Guangzhou Military Command from June 2018 to June 2019. The diagnose of ischemic stroke is made using the diagnostic criteria of the International Association of Neurological Diseases and Stroke Association in 1982. The classification criteria for subcortical ischemic stroke are based on the current international TOAST etiological classification method. It is a randomized, controlled, single-blind, longitudinal trial which has approved by the ethics committee of Guangzhou General Hospital of Guangzhou Military Command, and all patients and their guardian should sign an informed consent. The patients will divide into the venlafaxine group and the control group according to the principle of randomization (random number table). The patients in the venlafaxine group begin to take a venlafaxine hydrochloride capsule after enrollment ( each containing venlafaxine 75mg), qd, until 4 weeks after randomization, and the control group do not. Assessments of language functional behavior and examines of functional magnetic resonance imaging (fMRI) should be performed on the first days (Visit1,V1), 28±3 days (Visit2, V2) and 90±3 days (Visit3, V3) after randomization. Language functional behavioral assessments included the Chinese version of Western Aphasia Battery(WAB), spontaneous language frequency test(SLFT) and picture naming test(PNT). Examines of fMRI included task-state fMRI and resting-state fMRI. All patients received language rehabilitation training (twice a week, one hour each) which will be conducted by a professional rehabilitation physiotherapist from the Visitation1 until the end of Visitation3. The blood pressure and heart rate of each patient will be monitored and recorded on each visit, and two routine blood tests are performed at V0 and V3, including the blood routine and the liver and kidney function. The test sample quantity is estimated using the sample size estimated by the professional software nQuery Advisor7.0. According to the main evaluation index of the effect of the previous literature on the efficacy of venlafaxine, the experimental group and the control group are 7.5±3.8 and 4.3±2.6，The standard deviation will be 3.26, and 0.05 will be the statistical meaning level (double tail). The test efficiency will be set to 0.83. The balance design will be used to estimate the sample size of the experimental group and the control group in 16 cases. In addition, considering the 20% missing rate, a total of 45 samples will be included in the study. Task-state fMRI: an fMRI block design will be adopted, and DMDX software will be used to present each picture in series alternated between baseline (B) and activation (A) \[B-A-B-A-B…\]. Thirty-six animal pictures and 36 tool pictures accurately recognized by all subjects will be selected from the Snodgrass picture database. Six blocks of animal naming and six blocks of tool naming will be repeated, and each block continued for 18s with six pictures.the block-design diagram of picture naming task. The abstract figure of an American skunk which is unrecognized by all the subjects will be selected for baseline of animal naming. A schematic drawn arrow will be chosen for baseline picture of tool naming.Patients will be required to silently name the object in each picture without moving their lips. To avoid practice effects, the pictures used for activation will be different from those used in the behavioral evaluation. In the baseline phase, the participants will be asked to identify the orientation of the pictures by silently saying upright or inverted. The subjects will receive task familiarization training prior to the test to ensure that there will be no substantive picture naming but only positional judgment in the baseline task. Rest-state fMRI: During the rest-state fMRI scan, no task instruction will be given to the patient, and the patient will be completely relaxing, closing his eyes, breathing calmly, keeping his head still, but can not fall asleep, try to avoid any systematic thinking activities, scanning 8min. Functional magnetic resonance data acquisition The cranial brain scan will be performed using the US GE Signa HDx 3.0T Tesla superconducting magnetic resonance imaging system. The scanning sequence and parameters are as follows: 1. T1 structure imaging using FSPGR BRAVO sequence. The parameters included: time of repetition, 8.86 ms; time of echo, 3.52 ms; field of view, 24×24 cm2; in-plane resolution,256×256; slice thickness, 1 mm;interslice gap, 1 mm; and number of slices, 176. 2. Echo-Planar Imaging (EPI) is used to acquire task-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. Scan a sequence of 240s, a total of 12 min. 3. Echo-Planar Imaging (EPI) is used to acquire rest-state fMRI data.The parameters included: time of repetition, 3000ms; time of echo, 40 ms; field of view, 24×24 cm2; in-plane resolution,64×64; slice thickness, 4 mm; interslice gap, 1 mm; and number of slices, 34. A total of 8 min.
Interventions
DRUGVenlafaxine 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
Sponsors
Guangzhou General Hospital of Guangzhou Military Command
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The investigator learned about the experimental grouping and medication situation, but the subjects did not know until the end of the experiment.
Intervention model description
On the basis of conventional clinical treatment in both groups, the experimental group was given drug intervention, and the control group was not given drug treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： * The first stroke of the left single subcortical areas, within 72hours. * Primary school or higher level,aged between 18-75, native language Chinese * According to the commonly used eye chart examination, the corrected visual acuity is more than 1.0. * According to the Edinburgh Handedness Questionnaire (EHQ) as the right handed. * The language function was normal before the onset. After the onset, the language function was mildly to moderately impaired with Western Aphasia Battery (WAB) ( Aphasia Quotient (AQ) between in 60 to 88) * The patient cooperate with the examination, they and their guardian signed the informed consent
Exclusion criteria
： * History of organic diseases of the nervous system and history of craniocerebral trauma. * History of epilepsy and psychosis. * History of material dependence. * Decompensation of important organ function. * Hamilton Depression Scale(HAMD )\>8 points. * Hamilton Anxiety Scale(HAMA )\>7 points. * The Mini-Mental State Examination (MMSE)score \<20 points. * Dysphagia(difficult to take capsules). * A history of allergens in component of venlafaxine. * Pregnant women and breast-feeding women. * Contraindication of MRI.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 16 |
| 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. | 16 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Visitation 1 | Lack of Efficacy | 1 | 1 |
| Visitation 2 | Lack of Efficacy | 0 | 1 |
| Visitation 2 | Lost to Follow-up | 1 | 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
| Characteristic | Venlafaxine Group | Total | Controlled Group |
|---|---|---|---|
| Age, Customized Age | 55.19 years STANDARD_DEVIATION 10.94 | 54.62 years STANDARD_DEVIATION 9.42 | 54.06 years STANDARD_DEVIATION 9 |
| Body Mass Index（BMI） | 23.28 kg/m^2 STANDARD_DEVIATION 1.2 | 23.22 kg/m^2 STANDARD_DEVIATION 1.24 | 23.15 kg/m^2 STANDARD_DEVIATION 1.31 |
| Education Level | 8.63 years STANDARD_DEVIATION 3.07 | 8.54 years STANDARD_DEVIATION 2.77 | 8.44 years STANDARD_DEVIATION 2.25 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment China | 16 participants | 32 participants | 16 participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Male | 9 Participants | 20 Participants | 11 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Diabetes No | 13 Participants | 25 Participants | 12 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Diabetes Yes | 3 Participants | 7 Participants | 4 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Hyperlipidemia No | 9 Participants | 17 Participants | 8 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Hyperlipidemia Yes | 7 Participants | 15 Participants | 8 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Hypertension No | 4 Participants | 7 Participants | 3 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Hypertension Yes | 12 Participants | 25 Participants | 13 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Smoking No | 10 Participants | 19 Participants | 9 Participants |
| Vascular Risk Factors（Hypertension, Diabetes, Hyperlipidemia, Smoking） Smoking Yes | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 16 |
| other Total, other adverse events | 0 / 16 | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 | 0 / 16 |
Outcome results
Primary
A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Venlafaxine Group | 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 |
| Venlafaxine Group | 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 |
| Controlled Group | A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Visitation 1 | 78.60 score on a scale | Standard Deviation 6.38 |
| Controlled Group | A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Visitation 2 | 83.51 score on a scale | Standard Deviation 5.37 |
| Controlled Group | A Change of Outcome Measure:the Chinese Version of Western Aphasia Battery(WAB) | Visitation 3 | 88.55 score on a scale | Standard Deviation 3.95 |
Secondary
A Change of Outcome Measure:Picture Naming Test(PNT)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 1 | 39.19 score on a scale | Standard Deviation 5.19 |
| Venlafaxine Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 2 | 46.75 score on a scale | Standard Deviation 4.36 |
| Venlafaxine Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 3 | 52.25 score on a scale | Standard Deviation 2.6 |
| Controlled Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 1 | 38.31 score on a scale | Standard Deviation 5.23 |
| Controlled Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 2 | 43.31 score on a scale | Standard Deviation 4.45 |
| Controlled Group | A Change of Outcome Measure:Picture Naming Test(PNT) | Visitation 3 | 48.31 score on a scale | Standard Deviation 3.96 |
Secondary
A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 1 | 5.31 score on a scale | Standard Deviation 1.99 |
| Venlafaxine Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 2 | 9.31 score on a scale | Standard Deviation 1.54 |
| Venlafaxine Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 3 | 12.69 score on a scale | Standard Deviation 1.49 |
| Controlled Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 1 | 5.75 score on a scale | Standard Deviation 1.81 |
| Controlled Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 2 | 8.13 score on a scale | Standard Deviation 1.5 |
| Controlled Group | A Change of Outcome Measure:Spontaneous Language Frequency Test(SLFT) | Visitation 3 | 10.81 score on a scale | Standard Deviation 1.33 |
Secondary
Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA)
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 1 | 4.88 score on a scale | Standard Deviation 0.89 |
| Venlafaxine Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 2 | 4.13 score on a scale | Standard Deviation 0.96 |
| Venlafaxine Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 3 | 3.56 score on a scale | Standard Deviation 0.89 |
| Controlled Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 1 | 4.63 score on a scale | Standard Deviation 1.09 |
| Controlled Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 2 | 4.00 score on a scale | Standard Deviation 0.73 |
| Controlled Group | Follow-up Measurement: Hamilton Anxiety Rating Scale (HAMA) | Visitation 3 | 3.25 score on a scale | Standard Deviation 0.78 |
Secondary
Follow-up Measurement: Hamilton Depression Rating Scale (HAMD)
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 1 | 5.63 score on a scale | Standard Deviation 0.96 |
| Venlafaxine Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 2 | 4.94 score on a scale | Standard Deviation 0.57 |
| Venlafaxine Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 3 | 4.06 score on a scale | Standard Deviation 0.93 |
| Controlled Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 1 | 5.25 score on a scale | Standard Deviation 0.93 |
| Controlled Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 2 | 4.63 score on a scale | Standard Deviation 0.81 |
| Controlled Group | Follow-up Measurement: Hamilton Depression Rating Scale (HAMD) | Visitation 3 | 3.88 score on a scale | Standard Deviation 0.72 |
Secondary
Follow-up Measurement: Mini-Mental State Examination (MMSE)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Venlafaxine Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 1 | 23.81 score on a scale | Standard Deviation 1.22 |
| Venlafaxine Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 2 | 25.38 score on a scale | Standard Deviation 0.96 |
| Venlafaxine Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 3 | 26.38 score on a scale | Standard Deviation 0.81 |
| Controlled Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 1 | 23.88 score on a scale | Standard Deviation 1.15 |
| Controlled Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 2 | 25.00 score on a scale | Standard Deviation 1.03 |
| Controlled Group | Follow-up Measurement: Mini-Mental State Examination (MMSE) | Visitation 3 | 26.19 score on a scale | Standard Deviation 0.83 |