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Trial record 29 of 2453 for:    NMDA

NMDA Antagonists in Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01833897
Recruitment Status : Completed
First Posted : April 17, 2013
Results First Posted : June 1, 2016
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Standard of Care
Drug: Ketamine
Drug: D-cycloserine
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Period Title: Overall Study
Started 8
Completed 7
Not Completed 1
Reason Not Completed
Lack of Efficacy             1
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
37  (16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
5
  62.5%
Male
3
  37.5%
Montgomery Asberg Depression Rating scale   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
29  (6)
[1]
Measure Description: Measure of depression: Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60
Hamilton Depression Rating Scale (HAM-D)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
18.8  (6.7)
[1]
Measure Description:

Depression rating scale: Range 0-53, higher scores indicate worse depression.

0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression

≥ 23 = Very Severe Depression

Hamilton Depression Rating Scale (HAM-D) suicide item   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
1.25  (0.9)
[1]
Measure Description: Item 3 of scale (range 0-4) with higher scores indicating higher symptoms
Loss of Motivated Behavior HAM-D Factor   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
5  (1.6)
[1]
Measure Description: Includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms.
Hamilton Anxiety Rating Scale (HAM-A)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
12.6  (4.2)
[1]
Measure Description: Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indi- cates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.
Beck's depression inventory   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 8 participants
31.4  (10.4)
[1]
Measure Description:

Ranges from 0-63, with Higher total scores indicate more severe depressive symptoms.

The standardized cutoffs used:

0–13: minimal depression 14–19: mild depression 20–28: moderate depression 29–63: severe depression.

Time of treatment resistance  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 8 participants
3.3  (4)
1.Primary Outcome
Title Hamilton Depression Rating Scale (HAM-D)
Hide Description

Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression

≥ 23 = Very Severe Depression

Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
bipolar depression
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description:
Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale (final score)
9.5  (7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine and DCS Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments F1,6.4=161.8,
Method linear mixed model
Comments [Not Specified]
2.Secondary Outcome
Title Loss of Motivated Behavior HAM-D Factor
Hide Description includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
bipolar depression
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description:
Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale (final score)
1.6  (1.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine and DCS Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
3.Secondary Outcome
Title HAM-D Suicide Item
Hide Description Ham-D suicide item: range 0-4, higher scores indicate worse symptoms
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description:
Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale (final)
0.3  (0.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine and DCS Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title Hamilton Anxiety Scale
Hide Description Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0–56, where <17 indi- cates mild severity, 18–24 mild to moderate severity and 25–30 moderate to severe.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description:
Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale (final score)
6.4  (5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine and DCS Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title Beck's Depression Inventory
Hide Description Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description:
Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: units on a scale (final score)
10.8  (9.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketamine and DCS Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine and DCS Treatment
Hide Arm/Group Description Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
All-Cause Mortality
Ketamine and DCS Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ketamine and DCS Treatment
Affected / at Risk (%) # Events
Total   0/8 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine and DCS Treatment
Affected / at Risk (%) # Events
Total   4/8 (50.00%)    
Eye disorders   
phosphenes *  1/8 (12.50%)  1
Nervous system disorders   
headache  [1]  2/8 (25.00%)  2
sedation  [1]  3/8 (37.50%)  3
Psychiatric disorders   
hypomania  [2]  1/8 (12.50%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
mild
[2]
after stopping clinical medications
Limitations include the small-sample and a non-placebo controlled, open-label design.
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: Joshua Kantrowitz
Organization: New York State Psychiatric Institute
Phone: 646-774-6738
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01833897     History of Changes
Other Study ID Numbers: 6535
First Submitted: April 12, 2013
First Posted: April 17, 2013
Results First Submitted: March 17, 2016
Results First Posted: June 1, 2016
Last Update Posted: June 1, 2016