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The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning

This study has been completed.
Sponsor:
Collaborator:
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00566735
First received: December 3, 2007
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
Results First Received: June 5, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Major Depression
Bipolar Depression
Schizoaffective Disorder
Interventions: Drug: Razadyne
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
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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
Placebo Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
Galantamine Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.

Participant Flow:   Overall Study
    Placebo     Galantamine  
STARTED     20     19  
Withdrew Before Baseline Measures     2     7  
COMPLETED     18 [1]   12 [2]
NOT COMPLETED     2     7  
Withdrawal by Subject                 0                 1  
Refused neuropsychological testing                 2                 5  
Switched into a manic episode                 0                 1  
[1] 2 participants withdrew before baselines. Therefore, 18 participants will be included in baselines.
[2] 7 participants withdrew before baselines. Therefore, 12 participants will be included in baselines.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
Galantamine Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
Total Total of all reporting groups

Baseline Measures
    Placebo     Galantamine     Total  
Number of Participants  
[units: participants]
 		  18     12     30  
Age  
[units: Participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     14     9     23  
>=65 years     4     3     7  
Gender  
[units: Participants]
 		     
Female     11     6     17  
Male     7     6     13  
Wechsler Abbreviated Scale of Intelligence (WASI) [1]
[units: WASI Score]
Mean ± Standard Deviation 		  102.16  ± 18.21     104.57  ± 12.35     103.12  ± 15.87  
Hamilton Depression Rating Scale 17 (HAM-D-17) [2]
[units: HAM-D-17 Score]
Mean ± Standard Deviation 		  27.33  ± 4.33     24.53  ± 4.33     26.21  ± 4.33  
Subjective Mood  
[units: Subjective Mood Score]
Mean ± Standard Deviation 		  8.0  ± 1.54     7.88  ± 1.93     7.95  ± 1.70  
Clinical-Global Impressions - Severity (CGI-S) [3]
[units: CGI-S Score]
Mean ± Standard Deviation 		  4.75  ± 0.62     4.41  ± 0.87     4.61  ± .72  
Modified Mini Mental Status Exam (3MSE) [4]
[units: 3MSE Score]
Mean ± Standard Deviation 		  91.72  ± 8.05     90.41  ± 5.48     91.20  ± 7.02  
[1] The WASI is a standardized measurement of intelligence quotient (IQ). Scores range from 1 to 160, with 100 signifying average intelligence, scores above 140 signifying superior intelligence, and scores below 40 signifying severe intellectual impairment.
[2] This scale is a rater-administered assessment of depression severity and improvement. Scores range from 0 (not depressed) to 52 (severely depressed).
[3] This scale is a rater-administered assessment of severity of symptoms. 1 = Normal, not ill at all; 2 = Borderline ill; 3 = Mildly ill; 4 = Moderately ill; 5 = Markedly ill; 6 = Severely ill; 7 = Among the most extremely ill patients
[4] The 3MSE is a rater-administered test that assesses a broad variety of cognitive functioning. Scores range from 0 to 30. Scores greater than 25 indicate a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.



  Outcome Measures
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1.  Primary:   Number of Side Effects   [ Time Frame: Participants were followed for the duration of hospital stay, an average of 3 weeks ]
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2.  Secondary:   Cognitive Functioning   [ Time Frame: Participants were questioned at baseline and after their last electroconvulsive therapy treatment ]
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3.  Secondary:   Baseline Depressive Symptoms   [ Time Frame: Participants were questioned at baseline ]
  Show Outcome Measure 3


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


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 limitations of this study include a small sample size, absence of an optimal galantamine dose determination, and the inclusion of a heterogenous population including MDD, bipolar disorder, and schizoaffective order.  


Results Point of Contact:  
Name/Title: Dr. John Matthews
Organization: Massachusetts General Hospital
phone: 617-724-0847
e-mail: jmatthews@partners.org


No publications provided


Responsible Party: John D. Matthews, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00566735     History of Changes
Other Study ID Numbers: 2004-P-001051, GAL-EMR-4005
Study First Received: December 3, 2007
Results First Received: June 5, 2012
Last Updated: November 2, 2012
Health Authority: United States: Institutional Review Board