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Research Study for Major Depressive Disorder: Investigation of Glutamate Medications

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ClinicalTrials.gov Identifier: NCT00419003
Recruitment Status : Completed
First Posted : January 5, 2007
Results First Posted : March 21, 2016
Last Update Posted : March 21, 2016
Sponsor:
Collaborators:
National Alliance for Research on Schizophrenia and Depression
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Sanjay Johan Mathew, Baylor College of Medicine

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Major Depression
Interventions: Drug: Lamotrigine
Drug: Ketamine
Drug: Riluzole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The intent-to-treat sample (n=26) was recruited from media/internet advertising (14), psychiatrist referral (8), or self-referral from the New York Mood Disorders Support Group (4). Patients had marked depressive severity, chronicity, and anxiety comorbidity, and were highly pharmacotherapy-resistant.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2-wk psychotropic medication washout period (4 wk for fluoxetine)

Reporting Groups
  Description
Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II) Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
Placebo Pre-Treatment (Phase I)/Placebo (Phase II) Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)

Participant Flow for 2 periods

Period 1:   Phase I, Ketamine Infusion
    Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)   Placebo Pre-Treatment (Phase I)/Placebo (Phase II)
STARTED   13   13 
COMPLETED   7   7 
NOT COMPLETED   6   6 
Lack of Efficacy                6                6 

Period 2:   Phase 2, Riluzole/Placebo Follow-Up
    Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)   Placebo Pre-Treatment (Phase I)/Placebo (Phase II)
STARTED   6 [1]   8 [1] 
COMPLETED   5   8 
NOT COMPLETED   1   0 
Withdrawal by Subject                1                0 
[1] 14 completers of phase I didn’t split up evenly (same way as phase I) in the riluzole/placebo phase.



  Baseline Characteristics

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
Lamotrigine Pre-Treatment Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
Placebo Pre-Treatment Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
Total Total of all reporting groups

Baseline Measures
   Lamotrigine Pre-Treatment   Placebo Pre-Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   13   26 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.2  (11.8)   48.2  (11.8)   48.2  (11.8) 
Gender 
[Units: Participants]
     
Female   5   5   10 
Male   8   8   16 
Region of Enrollment 
[Units: Participants]
     
United States   13   13   26 


  Outcome Measures

1.  Primary:   Montgomery-Asberg Depression Rating Scale (MARDS) Score (Acute Response to IV Ketamine in Patients With Treatment Resistant Major Depression)   [ Time Frame: 24 Hours ]

2.  Secondary:   Efficacy of Lamotrigine in Decreasing IV Ketamine Psychotomimetic Side Effects   [ Time Frame: 24, 48, or 72-hrs ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
The open-label administration of ketamine limits interpretation of phase 1 results. The sample size was too small to detect moderators and mediators of response. Third,lack of placebo-controlled efficacy data supporting riluzole's use in depression.


  More Information

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. Sanjay Mathew
Organization: Baylor College of Medicine
phone: 7137985439
e-mail: sjmathew@bcm.edu


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

Responsible Party: Sanjay Johan Mathew, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00419003     History of Changes
Other Study ID Numbers: 05-0850
5M01RR000071-46 ( U.S. NIH Grant/Contract )
First Submitted: January 4, 2007
First Posted: January 5, 2007
Results First Submitted: September 5, 2013
Results First Posted: March 21, 2016
Last Update Posted: March 21, 2016