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Does Enhanced Glutamate Transporter Function Produce Antidepressant Effects in People With Major Depression?

This study has been terminated.
(Severe side effects & lack of target engagement)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02049385
First Posted: January 30, 2014
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Results First Submitted: July 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Depression
Interventions: Drug: Diazoxide
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diazoxide, Then Placebo Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was adjusted depending on side effects and response.
Placebo, Then Diazoxide Subjects received a matched placebo for three weeks.

Participant Flow for 2 periods

Period 1:   First Intervention
    Diazoxide, Then Placebo   Placebo, Then Diazoxide
STARTED   4   2 
COMPLETED   1   2 
NOT COMPLETED   3   0 

Period 2:   Second Intervention
    Diazoxide, Then Placebo   Placebo, Then Diazoxide
STARTED   1   2 
COMPLETED   1   0 
NOT COMPLETED   0   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
All Participants Subjects received 200-400 mg daily of diazoxide orally for three weeks; the dose was, adjusted depending on side effects and response.

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 6 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      6 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  50.0% 
Male      3  50.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1  16.7% 
Not Hispanic or Latino      5  83.3% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      6 100.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   MADRS Change at Day 7   [ Time Frame: 7 days ]


  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
As only 1 participant completed both treatment arms, no formal statistical analysis of the primary outcome (MADRS) possible. Study halted due to severe side effects & lack of target (KATP channel) engagement measured by insulin sensitivity index.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Zarate, Carlos
Organization: National Institute of Mental Health
phone: +1 301 451 0861
e-mail: zaratec@mail.nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier: NCT02049385     History of Changes
Other Study ID Numbers: 140041
14-M-0041 ( Other Identifier: The National Institutes of Health )
First Submitted: January 28, 2014
First Posted: January 30, 2014
Results First Submitted: July 20, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017