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Antidepressant Therapy in Treating Bipolar Type II Major Depression

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00602537
First received: January 15, 2008
Last updated: April 21, 2017
Last verified: April 2017
Results First Received: November 10, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Depression
Interventions: Drug: Venlafaxine
Drug: Lithium Carbonate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Antidepressant Therapy Venlafaxine: 75 to 375 mg
Mood Stabilizer Therapy Lithium Carbonate: 300 to 2400 mg

Participant Flow for 2 periods

Period 1:   12 Week Double Blind Comparison
    Antidepressant Therapy   Mood Stabilizer Therapy
STARTED   65   64 
Responded   44   22 
COMPLETED   42   17 
NOT COMPLETED   23   47 
Adverse Event                2                5 
Lack of Efficacy                13                23 
Lost to Follow-up                5                6 
Withdrawal by Subject                3                13 

Period 2:   Follow Up Study Comparison
    Antidepressant Therapy   Mood Stabilizer Therapy
STARTED   42   17 
COMPLETED   31   14 
NOT COMPLETED   11   3 
Adverse Event                1                0 
Lost to Follow-up                8                1 
Withdrawal by Subject                2                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
Antidepressant Therapy Venlafaxine: 75 to 375 mg
Mood Stabilizer Therapy Lithium Carbonate: 300 to 2400 mg
Total Total of all reporting groups

Baseline Measures
   Antidepressant Therapy   Mood Stabilizer Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 42   17   59 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.8  (11.4)   43.1  (15.2)   42.2  (12.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  57.1%      8  47.1%      32  54.2% 
Male      18  42.9%      9  52.9%      27  45.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   2.4%      0   0.0%      1   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4   9.5%      5  29.4%      9  15.3% 
White      37  88.1%      12  70.6%      49  83.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Inter-episode recovery 
[Units: Participants]
Count of Participants
 14   2   16 
Age 1st major depressive episode 
[Units: Years]
Mean (Standard Deviation)
 19.0  (7.7)   17.4  (5.4)   18.5  (7.1) 
Age 1st hypomanic episode 
[Units: Years]
Mean (Standard Deviation)
 20.7  (7.6)   16.2  (10.0)   19.4  (8.5) 
Number of lifetime major depressive episodes 
[Units: Episodes]
Mean (Standard Deviation)
 28.4  (50.4)   33.3  (49.7)   29.9  (11.0) 
Number of lifetime hypomanic episodes 
[Units: Episodes]
Mean (Standard Deviation)
 45.8  (66.4)   32.2  (47.3)   41.9  (61.4) 
Baseline HRSD score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 19.4  (3.6)   18.8  (3.3)   19.2  (3.5) 
[1] This scale refers to the 17-item Hamilton Rating Scale for Depression and measures patient depressive severity. The scale ranges from 0 to 52, with higher scores representing worse outcome.
Baseline YMRS score [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 0.8  (1.7)   0.6  (1.4)   0.8  (1.6) 
[1] This scale refers to the Young Mania Rating Scale and measures manic symptoms. The scale ranges from a minimum score of 0 to a maximum score of 60, with higher scores representing worse outcome.
Duration major depressive episode 
[Units: Months]
Median (Full Range)
 4.5 
 (.75 to 60) 
 4.0 
 (0 to 396) 
 4 
 (0 to 60) 
Baseline HRSD Score for Follow-Up study [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.3  (2.8)   4.4  (3.4)   4.3  (2.9) 
[1] This scale refers to the 17-item Hamilton Rating Scale for Depression and measures patient depressive severity. The scale ranges from 0 to 52, with higher scores representing worse outcome.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Depressive Relapse   [ Time Frame: Weeks 16, 20, 24, 30, 36 ]

2.  Secondary:   Treatment-Emergent Mood Symptoms   [ Time Frame: Measured at Weeks 12 and 36 ]


  Serious Adverse Events


  Other Adverse Events


  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
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  More Information
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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:  
Name/Title: Dr. Jay Amsterdam
Organization: University of Pennsylvania
phone: (215) 662-3462
e-mail: jamsterd@mail.med.upenn.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00602537     History of Changes
Other Study ID Numbers: R01MH060353-02 ( U.S. NIH Grant/Contract )
2R01MH060353-06A2 ( U.S. NIH Grant/Contract )
Study First Received: January 15, 2008
Results First Received: November 10, 2016
Last Updated: April 21, 2017