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The investigators hypothesize that patients receiving citalopram in combination with lithium will have a greater reduction in depressive symptoms than patients receiving citalopram in combination with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sugar pill | Placebo Comparator |
| |
| Lithium | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lithium Carbonate | Drug | 300 mg one time per day for 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sheehan-Suicidality Tracking Scale (S-STS) | The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4. | 4 weeks; from Baseline to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Hopelessness Scale (BHS) | The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts. Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4 | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arifulla Khan, MD | Northwest Clinical Research Center | Principal Investigator |
| Vishaal Mehra, MD | Aretmis Institute for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artemis Institute for Clinical Research | San Diego | California | 92123 | United States | ||
| Northwest Clinical Research Center |
After a patients enrolled in the study, the washout period for any excluded concomitant medications was kept to a minimum to avoid potential risk to this severely ill population.
There were 93 patients screened to meet the enrollment target of 80 randomized subjects into this study. Subjects were recruited from two clinical research centers beginning in March 2010. One site was located in Bellevue, WA, and the other in San Diego, CA. The last patient was screened in December 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Sugar Pill) | Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning. |
| FG001 | Lithium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
Take one time daily for 4 weeks |
|
| Citalopram | Drug | All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks) |
|
|
| Beck Scale for Suicide Ideation (BSS) | The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny. Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4 | 4 weeks |
| Bellevue |
| Washington |
| 98007 |
| United States |
Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Sugar Pill) | Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning. |
| BG001 | Lithium | Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Sheehan-Suicidality Tracking Scale (S-STS) | The S-STS is an 14 item clinician administered prospective rating scale that scores both treatment-emergent suicidal ideations and suicidal behaviors with scores ranging from 0-40 points. Patients scoring a 0 are experiencing no suicidal thoughts, ideations, or attempts, while a score of 40 indicates a fatal, completed suicide. Comparison was made between the citalopram with lithium and the citalopram with placebo treatment groups. Outcome measures are expressed as change scores from the baseline visit to week 4. | The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40). | Posted | Mean | Standard Deviation | Scores on a Scale (S-STSS) | 4 weeks; from Baseline to Week 4 | Suicidality scales | Participants |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Beck Hopelessness Scale (BHS) | The BHS measures the extent of negative attitudes about the future. It has particular utility as an indirect indicator of suicidal risk in depressed examinees or individuals who have made suicide attempts. Comparison between citalopram and lithium and citalopram and placebo groups in the BHS will be made from baseline to week 4 | Not Posted | 4 weeks | |||||||||||||||||||||||||||||||||||||
| Secondary | Beck Scale for Suicide Ideation (BSS) | The BSS is a 21-item slef-report instrument used to detect ans measure the severity of suicidal ideation in adults. It measures a broad spectrum of attitudes and behaviors for assessing patient suicide risk, as well as reveals specific suicidal characteristics which require greater scrutiny. Comparison between citalopram and lithium and citalopram and placebo groups in the BSS will be made from baseline to week 4 | Not Posted | Mean | Standard Deviation | Participants | 4 weeks |
Adverse event reporting began at the time the patient screened for the study and signed the informed consent document. AEs were collected at each study visit and follow up phone call and could be reported 30 days after last dose of study medication.
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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 | Placebo (Sugar Pill) | Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning. | 1 | 40 | 18 | 40 | ||
| EG001 | Lithium | Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning. | 1 | 40 | 21 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment | Patient reported that hospitalization post trial participation for worsening depression symptoms. |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment | Patient was hospitalized for worsening psoriasis during the screening period of the trial. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Headaches | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Decreased Appetite | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Anxiousness | Psychiatric disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Restlessness | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Common Cold | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
| |
| Upper Respitory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Operations | Columbia Northwest Pharmaceuticals | 425.453.0404 | jhobus@nwcrc.net |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D019263 | Dysthymic Disorder |
| D001883 | Borderline Personality Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D010554 | Personality Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D016651 | Lithium Carbonate |
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D002254 | Carbonates |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D002255 | Carbonic Acid |
| D017554 | Carbon Compounds, Inorganic |
| D018020 | Lithium Compounds |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| >=65 years |
|
| Male |
|