Borderline Personality Disorder, Depression Not Otherwise Specified, Dysthymia, Major Depressive Disorder
Conditions
Keywords
hopelessness, alone, sad, troubled, depression
Brief summary
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.
Interventions
DRUGLithium Carbonate
300 mg one time per day for 4 weeks
DRUGPlacebo
Take one time daily for 4 weeks
DRUGCitalopram
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)
Sponsors
Columbia Northwest Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 18-75 years of age * Meets criteria for Major Depressive Disorder, Dysthymia, Depression Not Otherwise Specified or Borderline Personality Disorder * Ability to speak, read and understand the English Language and provide written informed consent
Exclusion criteria
* Current, unstable and significant medical condition or illness * History of Thyroid disorder, seizure disorder, tumors or other CNS condition that predisposes the patient to risk of seizure * Pregnant or lactating females * Abnormal clinical laboratory test results * Intolerance or hypersensitivity to SSRIs or lithium * History or current diagnosis of bipolar mood disorder, psychosis, schizophrenia or dementia * Certain mediations my not be used prior or during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sheehan-Suicidality Tracking Scale (S-STS) | 4 weeks; from Baseline to Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Hopelessness Scale (BHS) | 4 weeks | 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 |
| Beck Scale for Suicide Ideation (BSS) | 4 weeks | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 40 |
| 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. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Moved out of State | 1 | 2 |
| Overall Study | Out of Window | 4 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Lithium | Placebo (Sugar Pill) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 39 Participants | 78 Participants |
| Age Continuous | 45.0 years STANDARD_DEVIATION 11.6 | 38.5 years STANDARD_DEVIATION 15.2 | 41.8 years STANDARD_DEVIATION 13.8 |
| Region of Enrollment United States | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 19 Participants | 25 Participants | 44 Participants |
| Sex: Female, Male Male | 21 Participants | 15 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 40 | 21 / 40 |
| serious Total, serious adverse events | 1 / 40 | 1 / 40 |
Outcome results
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.
Time frame: 4 weeks; from Baseline to Week 4
Population: The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo (Sugar Pill) | Sheehan-Suicidality Tracking Scale (S-STS) | 4.8 Scores on a Scale (S-STSS) | Standard Deviation 5.5 |
| Lithium | Sheehan-Suicidality Tracking Scale (S-STS) | 5.0 Scores on a Scale (S-STSS) | Standard Deviation 5.1 |
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
Time frame: 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
Time frame: 4 weeks