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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Columbia Northwest Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01189812
First received: March 18, 2010
Last updated: August 22, 2011
Last verified: August 2011
Results First Received: March 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Placebo (Sugar Pill)     Lithium  
STARTED     40     40  
COMPLETED     32     32  
NOT COMPLETED     8     8  
Withdrawal by Subject                 2                 3  
Adverse Event                 1                 0  
Out of Window                 4                 3  
Moved out of State                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Placebo (Sugar Pill)     Lithium     Total  
Number of Participants  
[units: participants]
  40     40     80  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     39     39     78  
>=65 years     1     1     2  
Age  
[units: years]
Mean ± Standard Deviation
  38.5  ± 15.2     45.0  ± 11.6     41.8  ± 13.8  
Gender  
[units: participants]
     
Female     25     19     44  
Male     15     21     36  
Region of Enrollment  
[units: participants]
     
United States     40     40     80  



  Outcome Measures

1.  Primary:   Sheehan-Suicidality Tracking Scale (S-STS)   [ Time Frame: 4 weeks; from Baseline to Week 4 ]

2.  Secondary:   Beck Hopelessness Scale (BHS)   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Beck Scale for Suicide Ideation (BSS)   [ Time Frame: 4 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events
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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.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5.0%  

Reporting Groups
  Description
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.
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.

Other Adverse Events
    Placebo (Sugar Pill)     Lithium  
Total, other (not including serious) adverse events      
# participants affected / at risk     18/40     21/40  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     5/40 (12.50%)     4/40 (10.00%)  
# events     5     4  
Vomiting † 1    
# participants affected / at risk     1/40 (2.50%)     2/40 (5.00%)  
# events     1     2  
Dyspepsia † 1    
# participants affected / at risk     0/40 (0.00%)     3/40 (7.50%)  
# events     0     3  
Infections and infestations      
Common Cold † 1    
# participants affected / at risk     2/40 (5.00%)     2/40 (5.00%)  
# events     2     2  
Nervous system disorders      
Somnolence † 1    
# participants affected / at risk     7/40 (17.50%)     6/40 (15.00%)  
# events     8     6  
Headaches † 1    
# participants affected / at risk     1/40 (2.50%)     9/40 (22.50%)  
# events     2     11  
Dizziness † 1    
# participants affected / at risk     2/40 (5.00%)     2/40 (5.00%)  
# events     2     2  
Decreased Appetite † 1    
# participants affected / at risk     2/40 (5.00%)     2/40 (5.00%)  
# events     2     2  
Restlessness † 1    
# participants affected / at risk     2/40 (5.00%)     0/40 (0.00%)  
# events     2     0  
Psychiatric disorders      
Anxiousness † 1    
# participants affected / at risk     2/40 (5.00%)     3/40 (7.50%)  
# events     2     3  
Respiratory, thoracic and mediastinal disorders      
Upper Respitory Infection † 1    
# participants affected / at risk     3/40 (7.50%)     0/40 (0.00%)  
# events     3     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (11.1)



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


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