SchizophreniaPhase 2NCT00728728

Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia

A Phase 2 study testing Dietary Supplement: Pregnenolone in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Dietary Supplement: Pregnenolone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 88 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Dec 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;
Gender: Males and Females;
Age: 21-65;
Caucasian or Non Caucasian;
Capable of providing informed consent;
Duration of illness equal to or greater than one year;

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No change in antipsychotic medication in the previous eight weeks, no change in antipsychotic dose in the previous four weeks;
No benzodiazepine use in the past twelve hours prior to cognitive testing;
The patient cohort will be enriched for cognitive symptoms (Composite BACS scores = 0-3 standard deviations below the mean, assessed at the screening visit).

Who cannot join

Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
Loss of consciousness (LOC) for more than 1 hour,
Recurring seizures resulting from the head injury,
Clear cognitive sequelae of the injury,
Cognitive rehabilitation following the injury;

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Subjects with unstable medical illness or neurological illness (seizures, CVA);
Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);
Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;
Pregnant women or women of child-bearing potential, who are either not surgically-sterile or not using appropriate methods of birth control (serum beta-human chorionic gonadotropin [HCG] will be performed at baseline, 4 weeks, and 8 weeks to exclude pregnancy);
Women who are breast-feeding;
Electroconvulsive therapy (ECT) treatment within the last 3 months;
Use of oral contraceptives or other hormonal supplementation such as estrogen. Although early studies suggested no effects on menstrual cycle, alterations in downstream metabolites of pregnenolone (such as estradiol) could theoretically impact the efficacy of oral contraceptives and/or estrogen replacement. Similarly, it is theoretically possible that pregnenolone could be metabolized to other steroids, resulting in hair, skin, or other steroid-related changes. Since we have determined in our prior study that pregnenolone administration does not result in downstream elevations in DHEA, DHEAS, estradiol, or testosterone, these possibilities may be unlikely;
Current active suicidal and/or homicidal ideation, intent, or plan;
Known allergy to study medication.

Trial locations and contacts

1 site in 1 country.

United States1 site

Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705

Other trials in United States

About this study

This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Dietary Supplement: Pregnenolone, Placebo
Keywords: pregnenolone, schizophrenia, cognitive, positive symptom, negative symptom, placebo control
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary Supplement: PregnenoloneDrug
Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.
PlaceboDietary supplement
Placebo

Study groups in NCT00728728
Study group	Role	What they receive
Arm 1: Pregnenolone	Active comparator	Pregnenolone Receives: Drug: Dietary Supplement: Pregnenolone
Arm 2: Placebo	Placebo comparator	Placebo Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

MATRICS Consensus Cognitive Battery (MCCB)
The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition.
The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
University of California Performance-based Skills Assessment (UPSA)
The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Brief Assessment of Cognition in Schizophrenia (BACS)
The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory \& Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Scale for the Assessment of Negative Symptoms(SANS)
The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)

Secondary outcomes (3)

The Calgary Depression Scale for Schizophrenia (CDSS)
The CDSS assesses the level of depression in schizophrenia by measuring nine items on a 0 (absent) to 3 (severe) scale each. Thus, the total score range is 0 to 27. Lower scores represent better outcomes.
Measured: Prospective, outcome measures collected over 10 week trial period.
Positive and Negative Syndrome Scale (PANSS)
The PANSS measures positive and negative symptoms of schizophrenia through administering a structured interview. After the interview, 25 PANSS items are each rated 1 (absent) to 7 (extreme). These items are organized into five scales: Negative, Positive, Dysphoric Mood, Activation, and Autistic Preoccupation. The combination of the 25 items produces a total score range of 25-175, and lower scores represent better outcomes.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Clinical Global Impressions (CGI) Scale
The CGI scale provides a brief, stand-alone assessment of the clinician's view of the patient's global functioning prior to and after initiating a study medication. The CGI comprises two companion one-item measures evaluating the severity of psychopathology from 1 to 7 and change from the initiation of treatment on a similar seven-point scale. Thus, scores range from 2 to 14, with lower scores representing better outcomes.
Measured: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Dec 2015

First posted6 Aug 2008 (estimated)
Study startDec 2009
Primary completionMar 2015
Study completionDec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00728728
Sponsor's protocol ID: MHBB-012-07F
Status last verified: Dec 2016
First submitted: 1 Aug 2008
Last updated: 10 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
ClinicalTrials.gov ID: NCT00728728
Acronym / sponsor ID: MHBB-012-07F
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: pregnenolone, schizophrenia, cognitive, positive symptom, negative symptom, placebo control
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: Dec 2009
Primary completion: Mar 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 6 Aug 2008 (estimated)
Results: Posted 10 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1: Pregnenolone	Active comparator	Drug: Dietary Supplement: PregnenolonePregnenolone
Arm 2: Placebo	Placebo comparator	Dietary Supplement: PlaceboPlacebo

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Diagnosis: DSM-IV/DSM-IV TR schizophrenia or schizoaffective disorder;
Gender: Males and Females;
Age: 21-65;
Caucasian or Non Caucasian;
Capable of providing informed consent;

Key exclusion criteria (15 listed)

Subjects with a DSM-IV/DSM-IV TR diagnosis of alcohol or substance dependence (other than nicotine) within the last month;
Subjects with a history of significant head injury/trauma, as defined by one or more of the following:
Subjects with unstable medical illness or neurological illness (seizures, CVA);
Patients with hormone-sensitive tumors (such as breast, uterine, or prostate cancer);
Clinically significant abnormalities in physical examination , ECG, or laboratory assessments;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Dietary Supplement: PregnenolonePregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.	Drug	Arm 1: Pregnenolone
PlaceboPlacebo	Dietary supplement	Arm 2: Placebo

Primary outcome

MATRICS Consensus Cognitive Battery (MCCB)
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders to measure cognition in these individuals. The MCCB consists of ten individually administered test which measure speed of processing, attention/vigilance, nonverbal working memory, verbal working memory, verbal learning, visual learning, reasoning and problem solving and social cognition. The primary raw scores are entered into the MCCB Computer Scoring Program which then generates the corresponding T-scores and percentiles, along with a graphic profile of the scores for each of the seven cognitive domains. Higher scores indicate better performance.
University of California Performance-based Skills Assessment (UPSA)
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
The UCSD Performance-based Skills Assessment (UPSA) is a measure of Functional Capacity and assesses skills involved in community tasks. It is composed of five subdomains (comprehension and planning, finance, communication, mobility and house management) when combined, measures functional capacity. The comprehension and planning subdomain ranges from 0 to 14, the finance subdomain ranges from 0 to 11, the communication subdomain ranges from 0 to 12, the mobility subdomain ranges from 0 to 9, and the house management subdomain ranges from 0 to 4. Then a medication management score of 0 to 37 is added. In total, the Assessment is thus scored on a 0 to 87 scale, with higher scores indicating better performance.
Brief Assessment of Cognition in Schizophrenia (BACS)
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
The Brief Assessment of Cognition in Schizophrenia (BACS) captures those domains of cognition that are the most severely affected in patients with schizophrenia and the most strongly correlated with functional outcome. The domains of cognitive function assessed and the associated tests include: Verbal Memory \& Learning (Verbal Memory), Working Memory (Digit Sequencing), Motor Function (Token Motor Task), Verbal Fluency (Semantic and Letter Fluency), Speed of Processing (Symbol Coding), and Executive Function (Tower of London). These domains are then converted to Z scores compared to standardized scoring scales, with higher scores representing better performance.
Scale for the Assessment of Negative Symptoms(SANS)
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
The Scale for the Assessment of Negative Symptoms (SANS) is an assessment used to obtain clinical ratings of negative symptoms in patients with schizophrenia. The SANS assesses five symptom complexes. They are: affective blunting; alogia (impoverished thinking); avolition/apathy; anhedonia/asociality; and disturbance of attention. 24 assessments are conducted on a six-point scale (0=not at all to 5=severe) each, for a total scoring range of 0-120. Lower scores represent better performance.

3 secondary outcomes

The Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Prospective, outcome measures collected over 10 week trial period.
Positive and Negative Syndrome Scale (PANSS)
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)
Clinical Global Impressions (CGI) Scale
Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)

Results and safety

Results posted to the registry on 10 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: Pregnenolone	42	38
Arm 2: Placebo	46	34

Primary outcome: MATRICS Consensus Cognitive Battery (MCCB)

Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10). Mean (Standard Error). Unit: T score

Measure	Arm 1: Pregnenolone n = 38	Arm 2: Placebo n = 34
Baseline	30.92 (1.83)	30.32 (1.40)
Week 4	33.43 (1.75)	32.76 (1.72)
Week 8	36.97 (1.90)	34.25 (2.11)

Primary outcome: University of California Performance-based Skills Assessment (UPSA)

Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10). Mean (Standard Error). Unit: total score

Measure	Arm 1: Pregnenolone n = 38	Arm 2: Placebo n = 34
Baseline	77.49 (1.63)	76.68 (1.76)
Week 4	77.29 (2.65)	80.12 (1.63)
Week 8	85.63 (1.31)	82.03 (2.05)

Primary outcome: Brief Assessment of Cognition in Schizophrenia (BACS)

Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10). Mean (Standard Error). Unit: Z score

Measure	Arm 1: Pregnenolone n = 38	Arm 2: Placebo n = 34
Baseline	-1.37 (0.13)	-1.53 (0.12)
Week 4	-1.11 (0.14)	-1.17 (0.12)
Week 8	-0.79 (0.13)	-1.09 (0.18)

Primary outcome: Scale for the Assessment of Negative Symptoms(SANS)

Time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10). Mean (Standard Error). Unit: total score

Measure	Arm 1: Pregnenolone n = 38	Arm 2: Placebo n = 34
Baseline	26.92 (1.75)	25.88 (1.94)
Week 4	23.87 (2.05)	21.74 (1.87)
Week 8	21.00 (2.47)	20.77 (2.40)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: Pregnenolone	3 of 42 (7.1%)	31 of 42 (73.8%)	Not reported
Arm 2: Placebo	4 of 46 (8.7%)	38 of 46 (82.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Schizophrenia

RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christine Marx, MD MA principal investigator

Durham VA Medical Center, Durham, NC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dietary Supplement: Pregnenolone in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MATRICS Consensus Cognitive Battery (MCCB) (time frame: Prospective, outcome measures collected over 10 week trial period. (Weeks 2, 6 and 10)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00728728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2017.