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Tryptophan MRI in People With Schizophrenia and Healthy Controls

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ClinicalTrials.gov Identifier: NCT02067975
Recruitment Status : Completed
First Posted : February 20, 2014
Results First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
Mitsubishi Tanabe Pharma Corporation
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Robert Buchanan, University of Maryland, College Park

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Tryptophan
Drug: Placebo
Enrollment 93
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Schizophrenia Related Disorders: Tryptophan First, Then Placebo Healthy Control: Tryptophan First, Then Placebo Schizophrenia Related Disorders: Placebo First, Then Tryptophan Healthy Control: Placebo First, Then Tryptophan Schizophrenia Related Disorders: Screening Only/Not Randomized Healthy Control: Screening Only/Not Randomized
Hide Arm/Group Description All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform. All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants had no psychiatric conditions. All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform. All participants received 6gs of placebo on the 2nd visit, and then received 6gs of tryptophan at the 3rd visit no less than two weeks apart at time zero of 7-hour visits 2 and 3. The order in which participants received either placebo or tryptophan was be randomized. The participant and the study staff did not know the order; only the pharmacist distributing the meds knew. These participants had no psychiatric conditions. All participants had not yet completed the screening phase or been randomized. These participants were diagnosed with Schizophrenia, Schizoaffective, or Schizophreniform. All participants had not yet completed the screening phase or been randomized. These participants had no psychiatric conditions.
Period Title: Overall Study
Started 20 18 21 18 8 8
Completed 16 16 19 14 0 0
Not Completed 4 2 2 4 8 8
Arm/Group Title Healthy Controls Schizophrenia Related Disorders Total
Hide Arm/Group Description All participants will receive both 6gm of tryptophan at least two weeks apart at time zero of 7 hour visits 2 and 3, and will also receive Placebo will be a liquid drink without tryptophan. 6mg at least two weeks apart at time zero of the 7 hour visits 2 and 3. The order in which participants receive either placebo or tryptophan will be randomized (ie. placebo first study visit day tryptophan on second study day, or tryptophan on first study day and placebo on second study day). Note that some of the participants included only participated in the screening and did not participate in the challenge phase of the study. All participants will receive both 6gm of tryptophan at least two weeks apart at time zero of 7 hour visits 2 and 3, and will also receive Placebo will be a liquid drink without tryptophan. 6mg at least two weeks apart at time zero of the 7 hour visits 2 and 3. The order in which participants receive either placebo or tryptophan will be randomized (ie. placebo first study visit day tryptophan on second study day, or tryptophan on first study day and placebo on second study day). Note that some of the participants included only participated in the screening and did not participate in the challenge phase of the study. Total of all reporting groups
Overall Number of Baseline Participants 44 49 93
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 49 participants 93 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
44
 100.0%
49
 100.0%
93
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 49 participants 93 participants
34.75  (11.70) 35.97959184  (9.847778506) 35.39784946  (10.72293335)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 49 participants 93 participants
Female
24
  54.5%
16
  32.7%
40
  43.0%
Male
20
  45.5%
33
  67.3%
53
  57.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 49 participants 93 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
   4.5%
2
   4.1%
4
   4.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
18
  40.9%
26
  53.1%
44
  47.3%
White
19
  43.2%
21
  42.9%
40
  43.0%
More than one race
5
  11.4%
0
   0.0%
5
   5.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants 49 participants 93 participants
44 49 93
1.Primary Outcome
Title Change in Verbal Memory Scores From Baseline to 4 Hours Post-Treatment
Hide Description The following assessment was used to assess the outcome measure: the Hopkins Verbal Learning Test-Revised (HVLT-R). HVLT total scores range from 0 to 36. In order to conduct group comparisons, the HVLT raw total scores are converted to a t-score (range: -10 to 80). The mean t-scores for each condition are below (see outcome measure data table). Higher scores represent better performance. Participants performed the same task before pre- and post-treatment with Tryptophan and again with placebo (2 weeks between conditions). Change in scores pre- and post-treatment were compared between the Tryptophan and placebo conditions.
Time Frame The order in which participants received either the tryptophan or placebo was randomized. The HVLT was administered 90 minutes prior to treatment and 4 hours post treatment. There were at least two weeks between the challenge days.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Healthy Controls: Placebo Schizophrenia Related Disorders: Placebo Healthy Controls: Tryptophan Schizophrenia Related Disorders: Tryptophan
Hide Arm/Group Description:
All participants received 6gm of placebo dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
All participants received 6gm of placebo dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
All participants received 6gm of tryptophan dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
All participants received 6gm of tryptophan dissolved in water. The HVLT was administered 90 minutes prior to placebo and 4 hours post placebo administration.
Overall Number of Participants Analyzed 30 37 31 37
Mean (Standard Deviation)
Unit of Measure: score on a scale
53.90  (8.01) 40.49  (11.27) 53.03  (9.53) 38.49  (10.77)
Time Frame A minimum of 5 weeks (there are a minimum of 2 weeks between visits and there are 3 visits)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Healthy Control: Tryptophan Schizophrenia Related Disorders: Tryptophan Healthy Controls: Placebo Schizophrenia Related Disorders: Placebo Healthy Controls: Screening Schizophrenia Related Disorders: Screening
Hide Arm/Group Description All participants received 6gm of tryptophan dissolved in water. All participants received 6gm of tryptophan dissolved in water. All participants received 6gm of placebo dissolved in water. All participants received 6gm of placebo dissolved in water. All participants had not yet completed the screening phase or been randomized. All participants had not yet completed the screening phase or been randomized.
All-Cause Mortality
Healthy Control: Tryptophan Schizophrenia Related Disorders: Tryptophan Healthy Controls: Placebo Schizophrenia Related Disorders: Placebo Healthy Controls: Screening Schizophrenia Related Disorders: Screening
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)      0/41 (0.00%)      0/36 (0.00%)      0/41 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Hide Serious Adverse Events
Healthy Control: Tryptophan Schizophrenia Related Disorders: Tryptophan Healthy Controls: Placebo Schizophrenia Related Disorders: Placebo Healthy Controls: Screening Schizophrenia Related Disorders: Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/36 (0.00%)      0/41 (0.00%)      0/36 (0.00%)      0/41 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Healthy Control: Tryptophan Schizophrenia Related Disorders: Tryptophan Healthy Controls: Placebo Schizophrenia Related Disorders: Placebo Healthy Controls: Screening Schizophrenia Related Disorders: Screening
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/36 (36.11%)      6/41 (14.63%)      0/36 (0.00%)      3/41 (7.32%)      1/8 (12.50%)      0/8 (0.00%)    
General disorders             
Nausea   7/36 (19.44%)  7 3/41 (7.32%)  3 0/36 (0.00%)  0 1/41 (2.44%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Syncope   1/36 (2.78%)  1 0/41 (0.00%)  0 /36  1/41 (2.44%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Vomiting   4/36 (11.11%)  4 1/41 (2.44%)  1 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Solemnence   0/36 (0.00%)  0 1/41 (2.44%)  1 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Sedation   2/36 (5.56%)  2 0/41 (0.00%)  0 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Hypotension   0/36 (0.00%)  0 0/41 (0.00%)  0 /36  1/41 (2.44%)  1 1/8 (12.50%)  1 0/8 (0.00%)  0
Headache   1/36 (2.78%)  1 2/41 (4.88%)  2 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Drowsniess   1/36 (2.78%)  1 0/41 (0.00%)  0 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Dizziness   2/36 (5.56%)  2 1/41 (2.44%)  1 /36  2/41 (4.88%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0
Anxiety   0/36 (0.00%)  0 1/41 (2.44%)  1 /36  1/41 (2.44%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Abdominal Pain   1/36 (2.78%)  1 0/41 (0.00%)  0 /36  0/41 (0.00%)  0 0/8 (0.00%)  0 0/8 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sam Kane-Gerard
Organization: Maryland Psychiatric Research Center
Phone: 410-402-6120
EMail: SGerard@som.umaryland.edu
Layout table for additonal information
Responsible Party: Robert Buchanan, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02067975    
Other Study ID Numbers: HP-00057861
1P50MH103222-01 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2014
First Posted: February 20, 2014
Results First Submitted: April 28, 2021
Results First Posted: August 26, 2021
Last Update Posted: August 26, 2021