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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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The objective of this study is to evaluate the efficacy of mecamylamine (MEC, 10 mg/day) versus placebo in reducing depressive and alcohol symptoms in patients with depression and co-morbid alcohol dependence. The researchers hypothesize that MEC will significantly reduce depressive symptoms and decrease alcohol consumption compared to placebo in patients with depression and alcohol dependence who are on a stable dose of a selective serotonin reuptake inhibitor (SSRI).
Depression with co-morbid alcohol dependence is very prevalent and it is very costly to treat. The co occurrence of the two disorders leads to greater severity and worse long-term outcome, including suicide. Although a number of treatment strategies have been implemented for depressed patients with alcohol dependence the controversy concerning best treatment options for those patients persists.
The clinical relationship between depression and alcohol dependence suggests some common mechanism underlying both disorders. It has been hypothesized that medications that block presynaptic nAChR may be effective in the treatment of alcoholism and depression. Mecamylamine (Inversine ®) is a noncompetitive, high affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Mecamylamine has never been investigated as an effective adjunct treatment for dually diagnosed patients with depression and alcohol dependence. Methods: Thirty participants with a current diagnosis of depression and alcohol dependence will be recruited for this 12-week treatment study. Fifteen participants will be randomized to mecamylamine and fifteen to placebo. Participants will be included in the study if: they meet current DSM-IV criteria for Major Depression and Alcohol Dependence and have been on a stable SSRI dose for 2 weeks. All participants will come weekly to take their medications and complete weekly assessments. Weekly assessments will consist of questioners that will assess depressive symptoms and alcohol consumption over the entire treatment period. Significance: This study is the first to evaluate the efficacy of mecamylamine as an augmenting agent for treatment of depression and alcohol dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mecamylamine | Experimental | Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks. |
|
| Placebo | Placebo Comparator | Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecamylamine | Drug | mecamylamine 10mg/day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Drinking Days | Measured with time line follow back measures | 25 weeks |
| Depression - Measured Using the HAMD Total Score | The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression) | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percentage of Number of Drinking Days by Smoking Status | Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo. | 25 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Ralevski, Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
284 subjects were assessed for eligibility, but 263 were excluded because they did not meet inclusion criteria or did not want to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mecamylamine | Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks. Mecamylamine: mecamylamine 10mg/day for 12 weeks |
| FG001 | Placebo | Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules. Placebo: Placebo pill |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants were included in the study if they met criteria for major depression and alcohol dependence, had been on a stable antidepressant dose for 2 weeks, and were either smokers or nonsmokers.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mecamylamine | Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks. Mecamylamine: mecamylamine 10mg/day for 12 weeks |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Drinking Days | Measured with time line follow back measures | Posted | Mean | Standard Deviation | days | 25 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mecamylamine | Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks. Mecamylamine: mecamylamine 10mg/day for 12 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting/Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Ralevski | Yale University School Of Medicine Department of Psychiatry | 203-932-5711 | 4282 | elizabeth.ralevski@yale.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008464 | Mecamylamine |
| ID | Term |
|---|---|
| D009636 | Norbornanes |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
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| Placebo |
| Drug |
Placebo pill |
|
| Mean Percentage of Heavy Drinking Days by Smoking | The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo. | 25 weeks |
| Placebo |
Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules. Placebo: Placebo pill |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Drinks per drinking day | Mean | Standard Deviation | drinks per day |
|
| Drinking days, past 30 | Mean | Standard Deviation | drinking days |
|
| Heavy drinking days, past 30 | Heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women | Mean | Standard Deviation | days |
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| Cigarettes per day | Mean | Standard Deviation | cigarettes |
|
| Total Alcohol Dependence Scale (ADS) score | The Alcohol Dependence Scale is made of 25 items that cover alcohol withdrawal symptoms, impaired control over drinking, awareness of a compulsion to drink, increased tolerance to alcohol, and salience of drink-seeking behavior. The scale can range from 0 to 47. The higher the value the greater the dependence. A score of 9 or more is highly predictive of DSM diagnosis of alcohol dependence. More specifically, a score from 1-13 indicates low dependence, 14-21 indicates intermediate, 22-30 indicates substantial, and 31-47 severe level of alcohol dependence. | Mean | Standard Deviation | units on a scale |
|
| Depression HAMD | The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression) | Mean | Standard Deviation | units on a scale |
|
| Smoking Status | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Depression - Measured Using the HAMD Total Score | The Hamilton Depression Rating Scale (HAM-D) has proven useful for many years as a way of determining a patient's level of depression before, during, and after treatment. It should be administered by a clinician experienced in working with psychiatric patients. Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. The Scale ranges from 0 (normal) to >23 (Very Severe Depression) | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
|
|
|
|
| Secondary | Mean Percentage of Number of Drinking Days by Smoking Status | Two-way interaction between smoking and medication for percentage of drinking days captured by time line follow back surveys. Data are calculated as number of drinking days over the number of days in the study for smokers and nonsmokers receiving either mecamylamine or placebo. | Posted | Mean | Standard Deviation | Percentage of Drinking Days | 25 weeks |
|
|
|
|
| Secondary | Mean Percentage of Heavy Drinking Days by Smoking | The two-way interaction between medication by smoking status to measure percentage of heavy drinking days measured by time line follow back survey. Data were calculated as number of heavy drinking days (heavy drinking days is defined as 5 drinks on a single occasion for men and 4 for women) over the number of days in the study for smokers and non smokers receiving either mecamylamine or placebo. | Posted | Mean | Standard Deviation | percentage of Heavy Drinking Days | 25 weeks |
|
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|
|
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | Placebo | Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules. Placebo: Placebo pill | 0 | 10 | 4 | 10 |
| Relapse to Drinking | General disorders | Systematic Assessment |
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| Worsening of Depression | Psychiatric disorders | Systematic Assessment |
|
| Calcified Granuloma | General disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |