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Trial record 86 of 536 for:    ESCITALOPRAM AND Disorders

Safety and Efficacy Study of Citalopram and Lithium for the Treatment of Depressive Mood Disorder Symptoms

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ClinicalTrials.gov Identifier: NCT01189812
Recruitment Status : Completed
First Posted : August 27, 2010
Results First Posted : June 8, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Columbia Northwest Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Major Depressive Disorder
Dysthymia
Depression Not Otherwise Specified
Borderline Personality Disorder
Interventions Drug: Lithium Carbonate
Drug: Placebo
Drug: Citalopram
Enrollment 80
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.
Arm/Group Title Placebo (Sugar Pill) Lithium
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 40 40
Completed 32 32
Not Completed 8 8
Reason Not Completed
Withdrawal by Subject             2             3
Adverse Event             1             0
Out of Window             4             3
Moved out of State             1             2
Arm/Group Title Placebo (Sugar Pill) Lithium Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  97.5%
39
  97.5%
78
  97.5%
>=65 years
1
   2.5%
1
   2.5%
2
   2.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
38.5  (15.2) 45.0  (11.6) 41.8  (13.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
25
  62.5%
19
  47.5%
44
  55.0%
Male
15
  37.5%
21
  52.5%
36
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Sheehan-Suicidality Tracking Scale (S-STS)
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population consisted of 80 patients randomized to lithium (n=40)or placebo (n=40).
Arm/Group Title Placebo (Sugar Pill) Lithium
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 40 40
Overall Number of Units Analyzed
Type of Units Analyzed: Suicidality scales
40 40
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale (S-STSS)
4.8  (5.5) 5.0  (5.1)
2.Secondary Outcome
Title Beck Hopelessness Scale (BHS)
Hide Description

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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Beck Scale for Suicide Ideation (BSS)
Hide Description

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
Outcome Measure Data Not Reported
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Sugar Pill) Lithium
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Placebo (Sugar Pill) Lithium
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Sugar Pill) Lithium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/40 (2.50%)    
Psychiatric disorders     
Depression * 1 [1]  1/40 (2.50%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Psoriasis * 1 [2]  0/40 (0.00%)  0 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.1)
[1]
Patient reported that hospitalization post trial participation for worsening depression symptoms.
[2]
Patient was hospitalized for worsening psoriasis during the screening period of the trial.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.0%
Placebo (Sugar Pill) Lithium
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/40 (45.00%)      21/40 (52.50%)    
Gastrointestinal disorders     
Nausea  1  5/40 (12.50%)  5 4/40 (10.00%)  4
Vomiting  1  1/40 (2.50%)  1 2/40 (5.00%)  2
Dyspepsia  1  0/40 (0.00%)  0 3/40 (7.50%)  3
Infections and infestations     
Common Cold  1  2/40 (5.00%)  2 2/40 (5.00%)  2
Nervous system disorders     
Somnolence  1  7/40 (17.50%)  8 6/40 (15.00%)  6
Headaches  1  1/40 (2.50%)  2 9/40 (22.50%)  11
Dizziness  1  2/40 (5.00%)  2 2/40 (5.00%)  2
Decreased Appetite  1  2/40 (5.00%)  2 2/40 (5.00%)  2
Restlessness  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Psychiatric disorders     
Anxiousness  1  2/40 (5.00%)  2 3/40 (7.50%)  3
Respiratory, thoracic and mediastinal disorders     
Upper Respitory Infection  1  3/40 (7.50%)  3 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Clinical Operations
Organization: Columbia Northwest Pharmaceuticals
Phone: 425.453.0404
EMail: jhobus@nwcrc.net
Layout table for additonal information
Responsible Party: Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01189812     History of Changes
Other Study ID Numbers: LP-DP-09201
First Submitted: March 18, 2010
First Posted: August 27, 2010
Results First Submitted: March 28, 2011
Results First Posted: June 8, 2011
Last Update Posted: August 24, 2011